Health Care — Landmark drug pricing legislation signed into law
This is not a repeat of the famous Michael Crichton novel, or movie that bears its name. A “de-extinction” CRISPR startup is hoping to get justice […]
This is not a repeat of the famous Michael Crichton novel, or movie that bears its name. A “de-extinction” CRISPR startup is hoping to get justice […]
On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell […]
What You Should Know: – Avenda Health, an AI healthcare company creating the future of prostate cancer care, has received FDA Investigational Device Exemption (IDE) for its FocalPoint […]
San Francisco has hired a hawk to scare pigeons away from metro stations. That may seem like a lot of effort to prevent pigeon poop, but apparently […]
The Food and Drug Administration (FDA) issued guidance on Thursday recommending that people testing themselves for COVID-19 at home take a repeat tests within 48 […]
The CEO of the company that makes the only vaccine approved by the Food and Drug Administration to prevent monkeypox told Biden administration health officials […]
More than 60 percent of all American adults take prescription drugs, amounting to approximately 131 million individuals. These drugs have been rigorously tested by regulatory […]
The Biden administration on Tuesday announced a new strategy to stretch the limited available doses of the Jynneos monkeypox vaccine by changing how the vaccine […]
The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, a new category of the disease that […]
Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted […]
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein […]
The Biden administration is considering splitting doses of the smallpox vaccine, which are being used to prevent monkeypox amid the current outbreak, into five smaller […]
What You Should Know: – The FDA has listed Mira’s new Mira Ovum Wand as an over-the-counter tool to detect the follicle-stimulating hormone (FSH) in […]
The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it […]
Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical […]
The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron […]
Addyi (flibanserin), the drug marketed for “hypoactive sexual desire disorder,” is ineffective and unsafe. What about dietary approaches for female sexual dysfunction? “The creation and […]
AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer […]
What You Should Know: – Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System […]
Kidney disease patients need access to innovative therapies to expand treatment choices and improve quality of life. The FDA should closely examine whether it is […]
What You Should Know: – Oncoustics, San Francisco, CA-based ultrasound-based tissue characterization solutions announces the initial close of a $5 million+ seed round of funding […]
What You Should Know: – RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received […]
The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. However, many firms were hit […]
Maggie Carmichael wasn’t developing like other kids. As a toddler, she wasn’t walking and had a limited vocabulary for her age. She was diagnosed with […]
This pet chicken from Vermont managed to travel more than 10 miles away from home in one piece and has now been reunited with her family after […]
The Food and Drug Administration will undergo an independent external review of its tobacco and food safety programs, commissioner Robert Califf announced Tuesday. The announcement […]
What You Should Know: – Caption Health, the leader in using artificial intelligence (AI) and services to improve heart ultrasound access, today announced that it […]
Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice […]
Forget covid-19, monkeypox, and other viruses for the moment and consider another threat troubling infectious disease specialists: common urinary tract infections, or UTIs, that lead […]
The Food and Drug Administration (FDA) on Wednesday sidestepped a major crackdown on companies that make popular synthetic nicotine products, drawing ire from Democrats and […]
What You Should Know: – Wysa, a Boston, MA-based AI digital platform for mental health, today announces it has secured $20M in financing led by […]
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The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the […]
In 2013, Tonya Taylor was suicidal because her epileptic seizures persisted despite taking a long list of medications. Then a fellow patient at a Denver […]
What You Should Know: – Today, Eko, a digital health company advancing heart and lung disease detection, has announced the FDA has issued clearance for its Eko Murmur Analysis […]
Anthony Fauci, the government’s top infectious disease expert, said Tuesday that a new omicron subvariant on the rise is something to take seriously but should […]
We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe […]
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers […]
The AMA believes physicians should still be the main prescribers, while advocates for provider status for pharmacists say it’s a win for health equity and […]
Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be […]
Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test […]
The Biden administration is working on a plan that will allow foreign manufacturers of infant formula to keep their products on the market in the […]
The Food and Drug Administration (FDA) on Wednesday issued a revision to its emergency use authorization (EUA) for Pfizer’s COVID-19 antiviral Paxlovid that will allow […]
The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that […]
The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely […]
Shane Cooke, CEO and President of Etiometry As the healthcare industry is experiencing major changes in the wake of the pandemic, how do we cut […]
FDA wants drugs to be more targeted to factors that impact patient’s lives in ways that they care about. To achieve this goal, last month […]
The grinding two-plus years of the pandemic have yielded outsize benefits for one company — Pfizer — making it both highly influential and hugely profitable […]
Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for […]
The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. […]
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New COVID-19 booster shots should be tailored to target omicron’s BA.4 and BA. 5 subvariants as well as the original strain in order to give […]
Pfizer on Thursday announced it had submitted an application to receive full approval from the Food and Drug Administration (FDA) for its COVID-19 antiviral Paxlovid […]
New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering […]
Like most healthcare markets, the diagnostic cardiology market has had a bumpy ride in recent years. The COVID-19 pandemic saw global revenues for Resting ECG […]
The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of […]
Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological […]
An expert advisory vaccine panel for the Food and Drug Administration (FDA) on Tuesday voted in favor of recommending updated COVID-19 vaccines specifically designed to […]
Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme […]
What You Should Know: – Today, an International Trade Commission (ITC) judge issued an Initial Determination that Apple infringed AliveCor’s valid patented technology – a finding that may result in […]
E-cigarette giant Juul argued in court documents filed on Tuesday that the Food and Drug Administration (FDA) had overlooked a mountain of data that it […]
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of […]
Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) […]
Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after […]
– Amazon Web Services (AWS) and MATTER, the premier healthcare incubator and innovation hub, announced the launched of a new incubation program called AWS Expand. […]
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The speed of Covid-19 vaccine trials should inspire the pharmaceutical and medical device industries to accelerate its clinical testing, according to Shweta Maniar, Google Cloud’s […]
Anti-smoking advocates said they are cautiously optimistic following a report that the Food and Drug Administration (FDA) is preparing to remove Juul’s vaping products from […]
The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. […]
First came the “edible billboard,” which appeared last year during the holidays in New York’s East Village loaded with cake treats. Then, in late January, […]
The Food and Drug Administration (FDA) is set to propose limits on the levels of nicotine tobacco companies can place in traditional cigarettes in an […]
AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation. […]
Acadia Pharma’s attempts to extend the indications of its Nuplazid drug in the US to include Alzheimer’s disease-related psychosis have suffered another major setback. Nuplazid […]
Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease […]
The Food and Drug Administration on Friday gave the green light to COVID-19 vaccines for children ages 5 and younger, a key step towards making […]
It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric […]
Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.). But it was […]
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The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health […]
Patricia (Pat) Black, Director of Technical Solutions at Cardinal Peak When it comes to your health and treatment, hospitals leverage a variety of sensors and […]
A few months ago, it seemed as though the country was poised to finally tame the pandemic, after two years of restrictions and tens of […]
China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment […]
A Food and Drug Administration (FDA) briefing document released Sunday said that Pfizer and BioNTech’s COVID-19 vaccine is safe and effective for children under 5. […]
bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its […]
C.K. Wang, Chief Medical Officer of COTA, Inc. In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes […]
The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far […]
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Follicular lymphoma patients in Europe now have a new treatment option. The European Commission approved Roche drug Lunsomio, a bispecific antibody designed to go after […]
What You Should Know: – TytoCare has partnered with Carilion Clinic, a not-for-profit health care organization serving Virginia’s Blue Ridge and Southwest Virginia regions. – The integration of TytoCare into Carilion’s current […]
An outside advisory panel voted overwhelmingly to recommend the Food and Drug Administration (FDA) authorize a COVID-19 vaccine made by Novavax for use in adults, […]
A brand of specialty mozzarella cheeses. A collection of natural-gas storage terminals. And America’s top-selling emergency contraception. At a moment when half of U.S. states […]
The federal government has established various departments and initiatives to promote cybersecurity among healthcare organizations, but experts say these efforts require more cross-agency collaboration in […]
A federal watchdog on Thursday said it will investigate whether the Food and Drug Administration (FDA) properly inspected an infant formula manufacturing plant operated by […]
As the Supreme Court appears poised to overturn Roe v. Wade, the landmark decision that guarantees the constitutional right to an abortion, reproductive rights advocates […]
What You Should Know: – Akili’s EndeavorRx, the first and only FDA-cleared video game ADHD treatment for kids, is uniting with Roblox’s global virtual universes forming a first-of-its-kind partnership. – […]
Federal regulators appear poised to finally authorize a COVID-19 vaccine from Novavax in the coming weeks, a move that the company hopes can help improve […]
Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee […]
Welcome to Thursday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: K-pop superstars BTS […]
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The nation’s infant formula shortage likely won’t be fully resolved until late July, the head of the Food and Drug Administration (FDA) told senators Thursday. […]
Novavax hitched its wagon to the global coronavirus pandemic. Before most Americans truly grasped the scope of the danger, the small Maryland biotech startup had […]
The Food and Drug Administration’s response to multiple reports of contamination at a baby formula manufacturing plant was delayed due to a COVID-19 outbreak and […]
A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their […]
Plaque psoriasis drug Vtama is now approved by the FDA, making it the first novel topical treatment for the chronic autoimmune disorder in a generation. […]
“I’ve got this,” coos Gal Gadot in Cue Health’s Super Bowl TV commercial. Cue hired the “Wonder Woman” actress to be the voice of the […]
The lead cancer drug candidate of Foghorn Therapeutics is now under a partial clinical hold following a patient death. According to the biotech, the patient […]
A handful of Republican lawmakers bucked their party on Wednesday in votes on two separate bills aiming to address the nationwide baby formula shortage causing […]
FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted […]
A nationwide shortage of baby formula has been at the top of the news cycle in the U.S. for weeks now as parents stress and […]
Americans generally don’t spend much time thinking about the nation’s blood supply. That’s mainly because the collection and distribution system is safe and efficient. But […]
The Food and Drug Administration (FDA) on Monday announced a series of measures aimed at increasing the domestic U.S. supply of infant formula to counteract […]
Baby formula manufacturer Abbott Nutrition on Monday said it has reached an agreement with the Food and Drug Administration (FDA) on a path to restart […]
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, […]
An early-stage drug that is being developed to tackle inflammatory and autoimmune diseases has been approved by the US regulator. Inmagene Pharma’s investigational new drug […]
The FDA approved Eli Lily drug Mounjaro as a treatment for type 2 diabetes. The decision gives the pharmaceutical giant a new competitor to a […]
The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is […]
The FDA has delivered a blow to UCB’s late-stage pipeline, after saying it is unable to approve its latecomer IL-17 inhibitor bimekizumab for moderate-to-severe plaque […]
It’s estimated that millions of people in the U.S. use period-tracking apps to plan ahead, track when they are ovulating, and monitor other health effects. […]
The prevalence of mental and behavioral health conditions has been on the rise in recent decades, further aggravated by the pandemic in the last two […]
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Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug […]
Deboshree Sarkar, Product Marketing Manager, PDF Editor Product line at Foxit We live in an increasingly digital world. Across industries, companies and consumers have come […]
Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World […]
The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that […]
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While Pfizer’s COVID-19 antiviral Paxlovid does offer a reduction in hospitalization and deaths, there is currently “no evidence” to suggest that prolonging and repeating a […]
What You Should Know: – Vivalink, a leading provider of digital healthcare solutions launches a multi-vital blood pressure patch for remote patient monitoring is now […]
Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare. Diversity […]
What You Should Know: – Hello Heart, the only digital therapeutics company focused exclusively on heart disease, announced a $70M Series D funding round led […]
What You Should Know: – Rochester Regional Health, an integrated health system serving western New York, the Finger Lakes, and beyond, announced it has selected […]
What You Should Know: – Houston Methodist and Colorado-based BioIntelliSense, a continuous health monitoring and clinical intelligence company, today announced a new collaboration to advance […]
The FDA has declined to approve two more cancer therapies developed by drugmakers based in China, in what may be further evidence of a tough […]
Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to […]
The Food and Drug Administration (FDA) on Friday released tentative June dates for its advisory committee to meet to discuss authorizing COVID-19 vaccines for young […]
Pfizer now has the regulatory O.K. to resume pivotal tests of its gene therapy for Duchenne muscular dystrophy—but with new limitations and safety measures. The […]
Moderna on Thursday asked the Food and Drug Administration to authorize its vaccine for children under six years of age, becoming the first company to […]
When new drugs are approved, FDA limits their on-label use to the treatment of specific diseases. A key question is whether the definition of a […]
Pfizer and BioNTech on Tuesday submitted an application to the Food and Drug Administration (FDA) requesting authorization to administer a booster dose of their COVID-19 […]
Rep. Neal Dunn (R-Fla.) on Tuesday said the controversial federal approval of the Alzheimer’s medication Aduhelm “muddied the waters” for other potential treatments for the […]
House Majority Whip James Clyburn (D-S.C.) on Monday requested a briefing from the Food and Drug Administration (FDA) on the status of COVID-19 vaccines for […]
What You Should Know: – Reify Health, a leading provider of solutions that empower the clinical trial ecosystem, announced a $220M Series D funding round dedicated […]
Employees from four agencies within the Department of Health and Human Services (HHS) said they did not report possible political interference in their work due […]
In March 2020, Dr. Joseph Vinetz left the contemplative world of his Yale University infectious-disease laboratory and plunged into the covid ward at Yale New […]
TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places […]
The Food and Drug Administration (FDA) says it is investigating Lucky Charms over dozens complaints it has received from customers who say they became ill […]
Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid […]
The Food and Drug Administration (FDA) now has oversight to regulate e-cigarette products from vaping companies operating under a loophole that was closed by a […]
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The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) on Tuesday issued warnings to two websites that the agencies said were illegally […]
What You Should Know: – Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally. – The algorithm will soon […]
An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead […]
A recent webinar sponsored by Formlabs underscored the value of 3D printing from a clinical perspective and offered insight on how commercial and regulatory players […]
Google has announced that the Food and Drug Administration (FDA) has cleared its product, Fitbit, to use a new feature that will identify atrial fibrillation […]
What You Should Know: – Arterys, the world’s leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI […]
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect […]
It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control […]
David Stein, CEO of Ash Wellness The rise of telemedicine and virtual care options have primed at-home testing to make a significant impact on the […]
The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee met on Wednesday along with other health officials and experts from around […]
A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by […]
The Food & Drug Administration (FDA) and a panel of health experts will meet Wednesday to discuss the future of COVID-19 boosters in the U.S. […]
Soon after Dr. Mai Fleming finished her medical residency in the San Francisco Bay Area, she got to work on her Texas medical license. The […]
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The […]
What You Should Know: – TytoCare, a provider of AI-powered, on-demand, remote medical exams has inked a partnership with MemorialCare, a health system in Orange and Los […]
Executives used to lean toward European regulators launching their products in that region. But after a decade of change, they now see the U.S. as […]
As pressure mounts on the U.S. Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their […]
The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety […]
By a narrow margin, an FDA advisory committee has voted against approval of Amylyx’ experimental medicine for amyotrophic lateral sclerosis until the company can provide […]
What You Should Know: – ConcertAI, LLC (ConcertAI), the leader in enterprise AI and real-world data (RWD) solutions for life sciences and healthcare, announced the […]
A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. […]
MEI Pharma and partner Kyowa Kirin have had to abandon plans to file for approval of their PI3K inhibitor zandelisib in B cell lymphoma, after […]
What You Should Know: – RedDress, a Florida-based Israeli medical company is shipping revolutionary blood-clotting wound care systems to Ukraine to help with serious injuries and severe trauma wounds. – RedDress began shipments of 400 of […]
What You Should Know: – Podimetrics raises $45M to help at-risk providers and health plans prevent diabetic amputations in high-risk patients. – With this latest […]
The FDA approved Pluvicto, a Novartis radiopharmaceutical, as a new treatment option for advanced prostate cancer. Novartis added the therapy via its $2.1 billion acquisition […]
What You Should Know: – Eko, a digital health company advancing heart and lung disease detection, today announced the launch of its newly-redesigned Eko App, […]
Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug […]
Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Armed with new data […]
Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The […]
When Pfizer CEO Albert Bourla said March 13 that all Americans would need a second booster shot, it struck many covid experts as a self-serving […]
Regulatory setbacks for a new migraine treatment have led Zosano Pharma to restructure, laying off about 31% of its staff. Zosano is one of several […]
What You Should Know: – Today, digital medicine leader physIQ and CellCarta, a global leader in precision medicine services announced they are collaborating on a groundbreaking study that could revolutionize vaccine development. […]
Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. […]
Mergers & Acquisitions (M&A) Activity OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform OptimizeRx, a provider of point-of-care technology solutions helping patients start and […]
Formlabs is sponsoring a webinar exploring 3D printing from clinical, commercial, and regulatory perspectives.
What You Should Know: – Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding […]
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What You Should Know: – MediView XR, Inc., raises $9.9M in SAFE financing syndicated by Inside View Investments, LLC, a private investment firm. MediView has raised approximately […]
US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the Food and Drug Administration’s (FDA) authority to […]
What You Should Know:– GoodRx announced that it will acquire vitaCare Prescription Services, a tech-enabled pharmacy services platform that expands GoodRx’s offering to pharma manufacturers while improving patient […]
Roger Massengale, Chief Commercial Officer, Eitan Medical January 2022 marked two years since the outbreak of COVID-19, with the healthcare system still working to adjust […]
The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer […]
What disease components are most burdensome to patients? How do researchers find this information out? To answer this question, the Food and Drug Administration (FDA) […]
The FDA approved drugs from Johnson & Johnson and CTI BioPharma in the past week. Complete response letters were issued to Gilead Sciences, Amryt, and […]
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple […]
What You Should Know: – XRHealth, the gateway to the healthcare metaverse, announced today that they raised $10M in funding to expand virtual healthcare treatment in the Metaverse. The […]
The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in […]
What You Should Know: – Viz.ai, a San Francisco-based provider of AI-powered intelligent care coordination for stroke, has received FDA 510(k) clearance for Viz ANEURYSM (formerly Viz ANX), the first and only AI-powered cerebral aneurysm detection solution […]
Vidya Murthy, Chief Operating Officer at MedCrypt Healthcare is a cyber criminal’s dream. It presents the intersection of a data treasure trove, weak security posture, […]
Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features […]
Genius Intelligent Endoscopy Module What You Should Know: – Medtronic and AWS, today announced a partnership to provide underserved communities with artificial intelligence (AI)-assisted colonoscopy […]
Jen Goldsmith, President Tendo Systems Healthcare data is increasing at an exponential rate. Approximately one-third of the world’s data volume is being generated by the […]
What You Should Know: – Sirona Medical, a software company with a cloud-native solution for radiologists, has announced its acquisition of Nines Radiology’s AI division. […]
What You Should Know: – EarliTec Dx, a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and […]
Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment […]
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The drug industry, patient advocates, and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve […]
It’s official – President Joe Biden’s choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote […]
Today, the Office of Generic Drugs (OGD) at the Food and Drug Administration (FDA) released its 2021 Annual Report. As noted in the report, 90% […]
El popular cóctel conocido como Moscow Mule (“Mula de Moscú”) supuestamente debe parte de su sabor a la jarra de cobre helada en la que […]
HELENA, Mont. — The popular cocktail known as the Moscow mule supposedly gets some of its flavor from the frosty copper mug it’s served in […]
FDA advisors have voted against approval of Eli Lilly and Innovent Biologics’ cancer immunotherapy sintilimab, undermining hopes of a new, lower-priced option in the PD-1/PD-L1 […]
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The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place […]
A rare disease drug that Sanofi added via its $11.6 billion Bioverativ acquisition is now approved for treating the blood disorder cold agglutinin disease. The […]
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for […]
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Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the […]
Robert Califf has made a series of commitments to try to win over senators reluctant to back his nomination as the next FDA commissioner, ahead […]
Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, […]
The U.S. Food and Drug Administration (FDA) approved a total of 60 new drugs in 2021. A new report from the FDA catalogs 50 new […]
Sierra Oncology myelofibrosis drug momelotinib achieved the main and secondary goals of a pivotal test and the biotech now plans to seek FDA approval. Sierra […]
The FDA has issued a complete response letter (CRL) to Merck & Co’s gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer […]
What You Should Know: – Biotricity, Inc. (NASDAQ:BTCY), a medical diagnostic and consumer healthcare technology company, today announced it has received 510(k) clearance from the U.S. […]
Merck is still at the front of the pack of companies developing new medicines to treat chronic cough, but the company was dealt a setback […]
The FDA has extended the emergency use authorisation for Gilead Sciences’ antiviral Veklury to include non-hospitalised patients with COVID-19, extending the uses of the drug. […]
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health […]
The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia […]
The US regulator has granted biliary tract cancer therapy Silmitasertib orphan drug designation. There are currently no treatments for this rare cancer, and the US […]
The FDA rejected the new drug application for a Levo Therapeutics treatment for the rare metabolic disorder Prader-Willi syndrome. According to Levo, the agency said […]
After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Under […]
Robert Califf has cleared another stage on his return journey to the top job at the FDA, after the influential Senate committee on Health, Education, […]
The FDA placed a clinical hold on Denali Therapeutics’ application to begin Phase 1 testing of an antibody drug for Alzheimer’s disease. The Denali drug […]
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BeyondSpring Pharmaceuticals’ corporate reorganization comes about six weeks after the FDA rejected the biotech’s drug for a complication experienced by cancer patients. The company still […]
It’s the first week of the new year, and the life sciences sector continued the IPO momentum of 2021 as Wall Street welcomed three new […]
Avrobio is stopping enrollment in a clinical trial for its Fabry disease program after new results showed variability in how the gene therapy was taken […]
The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of […]
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The […]
As in previous years, cancer products topped the list of new FDA-approved therapies in 2021. But the list of drug approvals is notable for other […]
The FDA has accepted Amylyx Pharmaceuticals’ submission for amyotrophic lateral sclerosis drug AMX0035 and it expects to issue a regulatory decision by late June. A […]
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that […]
Read about news from DermBiont, Janus Health, Embold Health, digital health draft guidance from the FDA, and more.
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track […]
Merck antiviral drug molnupiravir received emergency authorization, joining Pfizer’s Paxlovid as the only authorized oral antiviral drugs for treating Covid-19. Though the Merck and Pfizer […]
The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from […]
Novartis drug Leqvio now has the FDA’s green light, making it the first RNA interference medicine approved for lowering cholesterol. The regulatory decision sets the […]
Pfizer’s Paxlovid has become the first oral antiviral for COVID-19 to be authorised for emergency use by the FDA, as the US braces itself for […]
Can’t see the audio player? Click here to listen. Click here for a transcript of the episode. Rapid, at-home covid-19 tests are close to essential if […]
The FDA has halted tests of a Pfizer gene therapy for Duchenne muscular dystrophy. The clinical hold is one of several placed on gene therapy […]
The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed […]
Eleven months ago, President Joe Biden assumed office during one of the most critical moments of the covid-19 pandemic. Case counts and death rates were […]
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