Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the […]
AstraZeneca is withdrawing U.S. marketing of Imfinzi in bladder cancer after the drug failed a study required as a condition of its 2017 accelerated approval. […]
Shots: The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged […]
Shots: The US FDA has granted BTD to the tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable/ mUM The pre-planned interim analysis […]
In an alert on Friday, the Food and Drug Administration warmed that pulse oximeters might be inaccurate in some circumstances. The agency listed skin color […]
Shots: The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or […]
After Everlywell received an emergency use authorization last year from the FDA for its at-home collection kit, the agency gave Everlywell the green light to […]
The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry. The Center for […]
Shots: The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II […]
Kroger Health Partners with Gauss to Provide Smartphone-Enabled COVID-19 Rapid Antigen Home Tests What You Should Know: – Kroger Health, the healthcare division of The […]
Shots: The approval is based on P-III PARAGON-HF study involves assessing of Entresto (sacubitril/valsartan) in the treatment of patients with preserved ejection fraction HFpEF The […]
Shots: The US FDA has granted FT designation for ONCOS-102 based on pre/clinical efficacy associated with broad immune activation observed to date The designation is […]
What You Should Know: – ECRI Institute identified the complexity of managing medical devices with COVID-19 emergency use authorization as the number one technology hazard […]
Shots: The US FDA 510K clearance for stabilized urine samples to be used with the cobas BKV test on the cobas 6800/8800 systems. It is […]
Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one […]
Shots: The approval is based on three clinical trials involves assessing Trilaciclib +carboplatin/etoposide (+/- atezolizumab) and topotecan CT regimens in patients with ES-SCLC. 90% of […]
Shots: The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. […]
Can’t see the audio player? Click here to listen on SoundCloud. President Joe Biden has said he still wants a bipartisan bill to provide the next […]
Seagen and Genmab have announced they have filed their antibody-drug conjugate tisotumab vedotin with the FDA for patients with recurrent or metastatic cervical cancer. The […]
The EUA for Eli Lilly brings to patients a second antibody cocktail, following the FDA’s fall authorization of an antibody combination from Regeneron Pharmaceuticals. Lilly […]
Shots: The FDA authorized EUA for bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild to mod. COVID-19 patients aged ≥12yrs. who […]
Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or […]
Given the lead contamination found in candies containing chili imported from Mexico, 25 hot sauces were tested for heavy metals. “Lead toxicity is prevalent and […]
Shots: The FDA has approved eXciteOSA to treat mild obstructive sleep apnea and snoring by using for only 20 min./day for a period of 6 […]
Shots: The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. […]
Shots: The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad […]
Johnson & Johnson’s Covid-19 vaccine offers storage and distribution advantages compared to mRNA vaccines, and is the only single-shot vaccine to reach late-stage testing. The […]
The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis […]
The change of administration in the US has also seen a new leader at the FDA, with Dr Janet Woodcock appointed as interim commissioner by […]
Shots: The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against […]
Shots: The approval is based on pivotal P- II VISION study that involves assessing of Tepmetko (450mg, qd) as monothx. in 152 patients with a […]
EMD Serono’s Tepmetko is one of a number of targeted cancer therapies that have passed FDA muster in the past year. The decision sets up […]
The Neurocrine decision follows a clinical hold placed on the Parkinson’s program in December. It’s Voyager’s second loss of an R&D partner in the past […]
What You Should Know: – Health insurer Highmark expands access to FDA-cleared digital therapeutic Freespira proven to reduce the symptoms of panic disorder and PTSD […]
What You Should Know: – Casana raises $14M in Series A funding to pursue FDA clearance for its an IoT heart health toilet seat that […]
What You Should Know: – Syapse raises 68M in equity investment led by Ally Bridge Group (ABG), with Northpond Ventures to expand delivery of real-world […]
In a recent interview with PharmaShots, Laura Yecies, CEO of BoneHealth Technologies shared her views on OsteoBoost Vibration Belt that has been granted “Breakthrough Device” designation […]
Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and […]
Shots: The approval is based on DIAMOND-AF trial assessing the safety and efficacy of the DTA system vs contact force-sensing ablation system in 482 patients […]
Bristol-Myers Squibb’s commercial hopes for new multiple sclerosis drug Zeposia have yet to bear fruit thanks to the pandemic, but it’s already cued up a […]
What You Should Know: – SWORD Health raises $25 million in Series B to accelerate growth of its best-in-class virtual musculoskeletal care solution led by […]
The FDA has delayed its decision on aducanumab, the troubled Alzheimer’s drug from Biogen and Eisai by three months, raising hopes that it could be […]
Shots: The US FDA has granted FTD for GLR2007 for the treatment of patients with glioblastoma and application is eligible for Rolling Review and for […]
Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, […]
It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. […]
A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs […]
Shots: The approval is based on the pivotal AURORA P-III study and AURA-LV P-II study involves assessing of Lupkynis + SoC in 533 patients to […]
Shots: The approval is based on results from CheckMate -9ER, P-III pivotal trial involves assessing of Cabometyx + Opdivo vs sunitinib in 651 patients previously […]
President Joe Biden looks likely to ditch the previous administration’s move to create a quicker route to market for digital health products and other devices […]
Shots: The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen […]
Shots: The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment […]
The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the […]
Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. […]
Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for […]
Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn. Woodcock has […]
Shots: The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with […]
What You Should Know: – Tyto Care announces the launch of its fingertip Pulse Oximeter device, allowing users to measure their own blood oxygen saturation […]
Shots: The US FDA has accepted the BLA and granted the PR with an anticipated PDUFA date as Jul 17, 2021 The BLA filing marks […]
Shots: The approval is based on P-III ANDROMEDA (AMY3001) study involves assessing of Darzalex Faspro + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in […]
Shots: The approval is based on pivotal P-II DESTINY-Gastric01 trial involves assessing of Enhertu (6.4 mg/kg, q3w) vs CT in a ratio (2:1) in adult […]
Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new […]
Shots: The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment The therapy […]
Shots: The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL […]
The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage […]
AI tools increasingly occupy a regulatory gray area in healthcare. For clinicians to assess whether they are trustworthy, they need transparency on how they work, […]
What are some strategies to reduce arsenic exposure from rice? Those who are exposed to the most arsenic in rice are those who are exposed […]
Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of […]
The new tests can open a window into the duration of immunity and to the antibody levels needed to sustain it. But first, a universal […]
Getting rice down to the so-called safe water limit for arsenic would still allow for roughly 500 times greater cancer risk than is normally considered […]
Shots: The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) […]
In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his […]
What You Should Know: – TigerConnect has announced an expansion in their suite through the acquisition of Critical Alert, a leading provider of enterprise-grade middleware […]
Shots: The US FDA has granted EUA to Nirmidas’ COVID-19 rapid antibody IgG/IgM test for use in POC settings, delivering results in 15-20min Using a […]
Elsevier, the data analytics business specialized in science and health, and Heel, a pharmaceutical company specialized in developing and manufacturing medicines made from natural ingredients, […]
In an unusual move, the Food and Drug Administration issued an alert about false negatives in startup Curative’s Covid-19 test. The test was being used […]
Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK […]
Shots: The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has […]
When it comes to rice and rice-based products, pediatric nutrition authorities have recommended that arsenic intake should be as low as possible. “The US Food […]
What You Should Know: – The American Medical Association (AMA) announced the addition of three Current Procedural Terminology (CPT) codes for AstraZeneca’s COVID-19 vaccine. The […]
What You Should Know: – Amazon, CVS Health, Thermo Fisher Scientific join forces to promote employer-based testing As part of a comprehensive COVID-19 testing strategy. […]
What You Should Know: – Philips and BioIntelliSense has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $2.8M […]
Use Our Content It can be republished for free. The recent rollout of two newly authorized COVID-19 vaccines is a bright ray of hope at […]
One tray of COVID-19 vaccine from pharmaceutical giant Pfizer contains 975 doses — way too many for a rural hospital in Arkansas. But with the […]
Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to […]
As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The […]
An in-depth look at twelve recently released COVID-19 vaccine management solutions as COVID-19 vaccines are being distributed nationwide. 1. Microsoft Microsoft launches a COVID-19 vaccine […]
The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted […]
GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the […]
Pawel Czech, Founder of Nex.D While countries around the world continue to flounder with regards to COVID-19 testing, everyone is wondering how national governments could […]
With the US and other major countries poised to begin national distribution of multiple FDA-approved COVID-19 vaccines, the cybersecurity threats to secure COVID19 vaccine distribution […]
Stuart Karten, Founder/President, Karten Design Medical device design has been going through sweeping changes over the last decade. Ten years ago, medical device companies weren’t […]
Novartis’ Entresto is on course to become the first drug to be approved in the US for a form of heart failure that is notoriously […]
Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing […]
The FDA authorized an at-home antigen test for Covid-19 developed by Ellume. It does not require a prescription.
Brown rice contains more arsenic than white rice, but the arsenic in brown rice is less absorbable, so how does it wash out when you […]
Si existe una cita con el destino, está escrita en el calendario del doctor Taison Bell. Al mediodía del martes 15 de diciembre, Bell, especialista […]
This story also ran on NBC News. It can be republished for free. If there’s such a thing as a date with destiny, it’s marked […]
The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s […]
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use […]
Arsenic levels were tested in 5,800 rice samples from 25 countries.The arsenic found in five servings of rice a week poses a hundred times the […]
What You Should Know: – LA-based Scanwell Health announced today that its at-home UTI test kits – featuring the first FDA-cleared urinalysis app that lets […]
What You Should Know: – Lightspeed Venture Partners, the VC behind Nest and GrubHub, is leading a $10 million round for Freespira, an FDA-cleared digital […]
Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that […]
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, […]
What You Should Know: – Pear Therapeutics today announced that it has successfully closed an $80 million Series D financing led by SoftBank Vision Fund […]
What You Should Know: – Digital health startup Kleva Health launches FDA authorized saliva at-home COVID-19 test kit and raises $1.5 million in seed funding. […]
A daily half-cup of cooked rice may carry a hundred times the acceptable cancer risk of arsenic. What about seaweed from the coast of Maine? […]
Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
With multiple COVID-19 vaccines rapidly heading toward approval, optometrists and dentists are pushing for the authority to immunize patients during routine eye exams and dental […]
This is the question that a recent paper by Chorniy et al. (2020) attempt to answer. This issue is clearly very relevant as the UK […]
US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. […]
Neela Montgomery, EVP & President at CVS Pharmacy/Retail CVS Health Corporation names Neela Montgomery Executive Vice President and President of CVS Pharmacy/Retail, effective November 30, […]
What You Should Know: – AliveCor announced they received FDA clearance of new algorithms for use with their personal EKG devices, KardiaMobile and KardiaMobile 6L. […]
Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become […]
Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib. […]
The San Francisco-based company aims to complete at least one Phase III study by 2025, and it is weighing an IPO next year to fund […]
The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. […]
The FDA has agreed to expedite development of two rare disease drugs from Sanofi. The most significant of the two announcements is the Priority Review […]
The Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the first COVID-19 diagnostic at-home test. The move will not have […]
The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.
What You Should Know: – White house coronavirus task force doubles down on rapid testing strategy to fight the coronavirus as some states say they […]
KHN Editor-in-Chief Elisabeth Rosenthal discussed how to manage unexpected health care costs with CBSN on Wednesday. Click here to watch Rosenthal on CBSN KHN chief […]
What You Should Know: – Bill & Melinda Gates Foundation awards Caption Health a $4.5M grant to support the development of an AI-guided lung ultrasound […]
Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered […]
What You Should Know: – Cardiopulmonary digital health company Eko raises $65M in Series C funding to close the gap between virtual and in-person heart […]
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for […]
President-elect Joe Biden made COVID-19 a linchpin of his campaign, criticizing President Donald Trump’s leadership on everything from masks and packed campaign rallies to vaccines. […]
Bristol-Myers Squibb posted a solid set of financial results for the third quarter, but shares slid on investor fears that a payout tied new product […]
What You Should Know: – The FDA just extended its research collaboration agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting cancer. – […]
Shots: The acceptance marks the first marketing application accepted for achondroplasia in the US with an anticipated PDUFA date as of Aug 20, 2021. The […]
Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data […]
What You Should Know: – Fern Health will reveal a first-of-its-kind collaboration with Mass General Hospital where it will inform existing and future digitally-delivered pain […]
Scrutiny of drug prices will continue whether Trump or Biden wins. But pharma can take steps to address critics and cut costs before they reach […]
What You Should Know: – Northwestern Memorial Hospital is the first in the nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including measurement of […]
Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert […]
The Los Angeles-based startup received a breakthrough device designation from the FDA for using VR to manage chronic pain. It recently published the results of […]
What You Should Know: – Scopio Labs announced FDA clearance of its AI-powered X100 microscope and decision support system with Full Field Peripheral Blood Smear […]
What You Should Know: – FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain – AppliedVR’s EaseVRx program […]
While there are encouraging signs of reimbursement falling in step with the move towards a more value-based healthcare system, what is needed now to further encourage healthcare […]
Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta takes the […]
Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety […]
What You Should Know: – FUJIFILM Medical Systems U.S.A., Inc. and Volpara Solutions announced the extension of their partnership to provide mammography facilities and clinicians […]
Scynexis has filed for FDA approval of its novel drug ibrexafungerp which – if approved – would be the first broad-spectrum antifungal to reach the […]
What You Should Know: – Nationwide disease registry Corrona has acquired virtual patient community HealthUnlocked, creating a first-in-class patient experience ecosystem. – The acquisition will […]
Harmony Biosciences has scored an expanded use for its Wakix narcolepsy drug to include cataplexy – a symptom of the sleep disorder that can cause […]
Shots: Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and […]
The FDA granted an emergency use authorization to an algorithm developed by Dascena to predict which Covid-19 patients might face unstable blood pressure or respiratory […]
What You Should Know: – Virta is expanding its suite of treatment options to include prediabetes reversal, obesity reversal, and type 2 diabetes management. – […]
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving […]
As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any COVID-19 vaccine the federal agency authorizes. […]
The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed […]
As the coronavirus pandemic broke out across the country, health care providers and scientists relied on the standard method for detecting respiratory viruses: sticking a […]
What You Should Know: – physIQ has been selected by the National Institute of Health (NIH) to develop an innovative AI-based COVID-19 digital biomarker solution […]
Good bacteria, those living in symbiosis with us, are nourished by fruits, vegetables, grains, and beans, whereas bad bacteria, those in dysbiosis with us and […]
Shots: The US FDA has granted ODD and RPD to the Taysha Gene Therapies’ TSHA-101 for GM2 Gangliosidosis. The company expects the therapy to enter […]
Shots: The US FDA and EMA has received ODD to Galecto’s GB0139 for the treatment of IPF. GB0139 showed significant reduction of YKL-40 biomarker in […]
President Donald Trump told the American people this week that convalescent plasma is a potential new treatment for COVID-19. His announcement followed the Food and […]
Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder […]
Shots: The US FDA has issued EUA for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for the detection of COVID-19. The test will be available […]
Shots: Onvision needle tip tracking technology will be exclusively available on the latest version of the B. Braun and Philips’ Xperius ultrasound system together with […]
The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization […]
While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in […]
Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, […]
The FDA has allowed a blood plasma treatment for COVID-19 to be administered under an Emergency Use license – but some have decried the move […]
The Trump administration’s latest effort to use COVID-19 rapid tests — touted by one senior official as a “turning point” in arresting the coronavirus’s spread […]
Shots: BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia The company also reported that EMA has begun […]
Shots: The US FDA has approved Janssen’s Darzalex + Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd) in two dosing regimen (70 mg/m2 , qw and 56 […]
Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged […]
US biotech BioMarin has hit back with a filing for a rare disease drug, after suffering what was described by analysts as a “major setback” […]
The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis […]
In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to […]
While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval […]
Shots: The US FDA has issued a complete response letter for the NDA of filgotinib to treat moderately to severely active RA. FDA has requested […]
Shots: The NDA submission is based on three clinical studies in which Trilaciclib was administered prior to chemotherapy treatment in patients with SCLC and has […]
Shots: The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage […]
The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic […]
XRHealth appoints Deepa Javeri as CFO and is significantly expanding their US headquarters. XRHealth, a Boston, MA-based provider of extended reality therapeutic applications and XR telehealth […]
Shots: The approval is supported by P-III SAkuraStar and SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx. & as an add-on therapy […]
What You Should Know: – Philips today announced the launch of its Rapid Equipment Deployment Kits, which provide doctors with critical care patient monitoring solutions they […]
The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease. […]
Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates […]
Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with […]
What You Should Know: – Today, Medtronic announced that it will acquire Companion Medical, the manufacturer of InPen, a smart insulin pen system paired with an integrated […]
What You Should Know: The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding […]
Shots: The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time […]
Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC […]
Shots: The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed […]
Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting […]
Shots: The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs The manual version of the […]
What You Should Know: – TransUnion, in partnership with CLX Health, a joint venture from UST Global and SiriusIQ, announced the launch of HealthyAmerica, a […]
Shots: The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for […]
Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no […]
DBV Technologies’ long and tortuous path to an FDA verdict on its Viaskin Peanut allergy shot has led to another dead end. The France-headquartered biotech […]
What You Should Know: – Eko today announced a global collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening […]
Shaving before applying underarm antiperspirants can increase aluminum absorption. Could this explain the greater number of tumors and the disproportionate incidence of breast cancer in […]
Oliver Schacht, PhD, CEO of OpGen Secondary bacterial or fungal co-infections in COVID-19 patients have received inadequate attention from the public. For most, co-infections pose […]
Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a […]
Millions of people, including the president of the United States, have seen or shared a video in which a doctor falsely claims there is a cure for […]
Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients […]
Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic (cobimetinib) + Zelboraf (vemurafenib) vs PBO + Cotellic + Zelboraf in […]
What You Should Know: – Philips receives 510(k) clearance from the FDA for its pre-hospital wireless monitoring solution (Tempus LS- Manual), now offering its remote […]
Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery […]
What You Should Know: – Ciox Health has acquired Medal, Inc., a biomedical Natural Language Processing (biomed-NLP) technology company. – The acquisition will lead Ciox to […]
Shots: The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms The tool utilizes the AI […]
Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r […]
Shots: The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol […]
AstraZeneca’s triple therapy for chronic obstructive pulmonary disease (COPD), Breztri Aerosphere (budesonide+glycopyrrolate+formoterol fumarate), has been approved in the US following a rejection last year. Approval […]
Shots: The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic pain or […]
Can’t see the audio player? Click here to listen on SoundCloud. President Donald Trump — who has spent the past six months trying to play down […]
What You Should Know: – Caption Health AI is awarded FDA 510(k) clearance for its innovative point-of-care ejection fraction evaluation. – Latest AI ultrasound tool […]
What You Should Know: – The National Institutes of Health (NIH) has granted next-generation cardiac AI company Eko an award totaling $2.7 million to support […]
Shots: The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC […]
Shots The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to […]
As the mother of a child with food allergies, Heather Sapp was well versed in reading labels and calling manufacturers to verify ingredients. For years, […]
Shots: The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. […]
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning […]
Shots: The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent […]
What You Should Know: – Digital surgery pioneer Activ Surgical raises $15M in funding led by ARTIS Ventures to accelerate U.S. commercialization and European expansion […]
Shots: The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF […]
An FDA advisory committee has narrowly voted in favour of approval of Mallinckrodt’s terlipressin for hepatorenal syndrome type 1 (HRS-1), after the agency questioned the […]
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the […]
The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the […]
What You Should Know: – Repurpose.AI, has partnered with Scripps Research to discover drug candidates that may be repurposed to treat COVID-19. – The partnership […]
What You Should Know: – Philips integrates the BioIntelliSense FDA-cleared BioSticker™ sensor as part of its remote patient monitoring solutions for patients outside the hospital. […]
Do BPA-free plastics such as Tritan, have human hormone-disrupting effects? And what about BPS and BPF? Recent human studies indicate that exposure to the plastics […]
As we discussed in an earlier blog post, real-world evidence can bring value to every stage of the drug life cycle, from early discovery to […]
As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and […]
Drug development is a multidisciplinary field that requires a drug to successfully pass through different stages — from chemical design to biological experimentation on cells […]
The majority of dietary supplement facilities tested were found noncompliant with good manufacturing practices guidelines. “The U.S. public is not well protected” by current […]
As I discuss in my video Which Intestines for Food and Cosmetics?, the Food and Drug Administration (FDA) recently reopened comments about its policy of […]
The approval of aspartame has a controversial history. The Commissioner of the U.S. Food and Drug Administration (FDA) concluded that “there is a reasonable certainty […]
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