Roche eyes April FDA verdict on Polivy as first-line lymphoma therapy
The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move […]
The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move […]
Beleaguered Biogen has been handed some encouraging news from the FDA, after the regulator agreed to complete its review of amyotrophic lateral sclerosis (ALS) therapy […]
Drugmakers Pfizer and Flynn Pharma have been fined £70 million ($84 million) by the UK Competition and Markets Authority (CMA) for overcharging the NHS for […]
A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical […]
Perrigo’s HRA Pharma subsidiary has become the first drugmaker in the US to seek approval for an over-the-counter contraceptive pill. The move comes as access […]
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’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 […]
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 […]
The FDA’s vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the […]
Manufacturing problems wreaked havoc with Mallinckrodt’s first attempt to secure FDA approval of its treatment candidate terlipressin for hepatorenal syndrome (HRS), but the drugmaker is […]
There’s a growing body of evidence that digital therapeutics (DTx) can complement other therapies for a wide range of health conditions, reducing costs and improving […]
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 […]
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 […]
The UK medicines regulator has awarded Alnylam’s RNAi-based therapy zilebesiran for hypertension an ‘innovation passport‘, a designation designed to speed up NHS access to promising […]
Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare […]
The payer policy rollercoaster has taken a few twists and turns recently, leaving healthcare organizations out of the loop if they try to keep pace […]
Shares in US biotech Nymox Pharma have plunged after the company announced the FDA had refused to accept its marketing application for its drug candidate […]
Companies trying to bring digital therapeutic (DTx) products through development and onto the market have been navigating in uncharted waters for years. Now, trade organisation […]
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 […]
Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which […]
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 […]
Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the […]
Teva’s long haul to a turnaround of its business has been dealt a blow by the FDA, which has just declined to approve the company’s […]
The Appropriate Use Criteria (AUC) program is due to come into full effect in January 2023 at the earliest. The program was established by the […]
AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal […]
Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs […]
Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare […]
Manufacturing problems seem to have scuppered Mallinckrodt’s hopes of bringing the first approved drug to market in the US for hepatorenal syndrome (HRS), a life-threatening […]
AbbVie has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part […]
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 […]
Traditional revenue cycle management strategies are on shaky ground. Time-consuming manual processes are struggling under the burden of increasing patient volumes and patient financial responsibility. […]
The UK Competition and Markets Authority has ruled that several drugmakers worked together to raise the NHS price of widely-used nausea drug prochlorperazine, fining them […]
US hospitals have provided more than $702 billion in uncompensated care over the last two decades. To protect profits, healthcare organizations must be vigilant about […]
The MHRA has kicked off an eight-week consultation on proposals for changes to laws governing the conduct of clinical trials following the UK’s departure from […]
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in […]
Shares in Applied Therapeutics slumped today after it said it would have to delay a US filing for its lead drug programme AT-007, following an […]
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 […]
The No Surprises Act, effective Jan. 1, 2022, requires that healthcare providers include a “Good Faith Estimate” that covers all relevant codes and charges. This […]
The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA […]
Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to […]
Robert Califf looks set to take a second term as FDA commissioner after navigating a relatively placid two-hour confirmation hearing in the US Senate, with […]
Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for […]
The FDA’s Bioresearch Monitoring (BIMO) program is implemented to ensure the protection of the rights, safety, and welfare of human research subjects and to ensure […]
BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead […]
Shots: NICE has issued a positive Final Appraisal Document which recommends Sunosi (75/150mg, qd) as an option treatment for adults with EDS caused by narcolepsy […]
Shots: The NMPA has approved a P-I/II SWATCH dose-escalation & dose-expansion study that evaluates the safety, tolerability, and preliminary efficacy of selinexor in combination with […]
Shots: The approval is based on the P-III KEYNOTE-564 trial evaluating Keytruda (200mg, IV, q3w for 1yrs.) vs PBO in a ratio (1:1) in 994 […]
Shots: The approvals are based on the clinical trials to evaluate mepolizumab vs PBO when added to SoC in patients with HES, EGPA & CRSwNP […]
Shots: The designation is based on the ongoing P-III DIALIZE-Outcomes trial to evaluate the effect of Lokelma on arrhythmia-related CV outcomes in patients with chronic […]
Shots: The approval is based on KEEPsAKE-1 & 2 studies to evaluate Skyrizi (150mg) vs PBO in patients with active PsA who had an inadequate […]
Shots: The approval is based on the data from PK bridging studies and P-III EVOLVE-MS-2 study to evaluate the GI tolerability of Vumerity vs Tecfidera […]
Shots: The EC has granted marketing authorisation for Celltrion’s regdanvimab in adults with COVID-19 who do not require supplemental oxygen & are at high risk […]
Shots: The designation is based on the results of the P-III JUPITER-06 clinical trial that evaluates toripalimab + CT vs CT alone in patients with […]
Shots: The EMA’s CHMP has adopted a positive opinion for the label extension of Kaftrio in combination with ivacaftor to treat CF in patients aged […]
Shots: The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorization for Lumykras to treat advanced NSCLC with KRAS G12C mutation & […]
Shots: The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization for Wegovy in adults with obesity in chronic weight management in adults […]
Shots: The EMA’s CHMP has issued a positive opinion recommending the marketing authorization for regdanvimab (CT-P59) in adults with COVID-19 who do not require supplemental […]
The FDA’s Bioresearch Monitoring (BIMO) program is implemented to ensure the protection of the rights, safety, and welfare of human research subjects and to ensure […]
Shots: The NDA is based on CENTAUR trial evaluates AMX0035 vs PBO in 137 patients with ALS The results showed that patients receiving AMX0035 had […]
Shots: The NMPA has approved an IND application for P-Ib MATCH, dose-escalation study to evaluate the safety of ATG-008 + ATG-010 in patients with r/r […]
Shots: The US FDA has accepted the BLA for toripalimab + CT (gemcitabine & cisplatin) & toripalimab as monothx. to treat advanced recurrent or metastatic […]
Shots: The submission is based on P-II studies i.e., CITADEL-203/204/205 that evaluate parsaclisib in patients with r/r FL, MZL & MCL. The anticipated PDUFA date […]
Shots: The approval is based on P-III ASCEMBL & P-I study that evaluates Scemblix in patients with Ph+ CML-CP with T315I mutation who had experienced […]
Shots: The MAA is based on the P-II LOTIS-2 study evaluating Zynlonta (CD19-directed ADC) in 145 patients with r/r DLBCL following two or more prior […]
Shots: The company will initiate the P-I/II dose-escalation & expansion study to evaluate the safety, PK & anti-tumor activities of IMP9064 as monothx. & in […]
Shots: The submissions are based on the P-II ELARA trial evaluates the efficacy and safety of Kymriah in adult patients with r/r FL after at […]
Shots: Health Canada has granted a NOC based on the P-II ZUMA-2 trial that evaluates Tecartus in 74 adult patients with r/r MCL who had […]
Shots: The MAA is based on the P-III TRuE-V clinical program that consists of 2 P-III studies ie., TRuE-V1 & V2 evaluating ruxolitinib cream in […]
Shots: The US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 […]
Shots: The submission is based on the P-III MOVe-OUT trial that evaluates molnupiravir (800mg, bid) in non-hospitalized adult patients with COVID-19 At the interim analysis, […]
Shots: The approval is based on P-III Archway study evaluates Susvimo (100 mg/mL, IV, q3mos.) via ocular implant vs ranibizumab (0.5mg, IV) in 415 patients […]
Shots: The CDC’s ACIP has voted to recommend Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) to protect adults against invasive disease and pneumonia caused by the […]
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The […]
Shots: The NICE has issued a final appraisal determination (FAD) which recommends Dupixent (dupilumab) as an add-on maintenance treatment for severe asthma The NICE recommendation […]
Shots: The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with […]
Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic […]
Shots: The opinion was based on the P-III KEEPsAKE-1 & 2 studies evaluate Skyrizi (150mg, SC) vs PBO in adults with active PsA who had […]
Shots: The approval is based on P-III IMpower010 study Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical […]
With rumours growing that that ex-FDA head Robert Califf looks set to receive President Joe Biden’s nomination to be the next FDA commissioner, at least […]
Shots: The CHMP’s recommendation is based on P-III True North study evaluating Zeposia as an induction and maintenance therapy vs PBO in adult patients with […]
Shots: The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis […]
Shots: NMPA’s CDE has approved the IND application of oral APL-1202 in combination with BeiGene’s tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder […]
Shots: The US FDA has accepted the sBLA and EMA has validated the type-II variation application for Beovu (brolucizumab, 6mg) for the treatment of DME. […]
Shots: The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors […]
Shots: The US FDA has granted ODD to the Ketamine for the treatment of complex regional pain syndrome (CRPS) which is a rare chronic pain […]
Shots: The US FDA has approved Verzenio + ET for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, EBC at high risk of […]
Shots: The approval is based on P-III IKEMA study assessing Sarclisa in combination with carfilzomib and dexamethasone (Kd) in 302 patients with relapsed MM who […]
Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in non-hospitalized adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes & […]
Shots: The designation is based on the data from an ongoing SCarlet RoAD, Marguerite RoAD OLE trials along with other studies evaluating gantenerumab (anti-amyloid beta […]
Shots: The company has submitted an sBLA to the US FDA for an expanded approval of Stelara (ustekinumab) to treat pediatric patients ≥aged 5yrs. with […]
Shots: The approval is based on the P-III clinical trial program including Measure Up 1/2/AD Up that evaluates the efficacy & safety of Rinvoq (15/30 […]
Shots: The US FDA’s AMDAC voted to recommend the use of maribavir (TAK-620) to treat refractory CMV infection and disease with/out genotypic resistance to ganciclovir, […]
Shots: The NICE has recommended Novartis’ Adakveo (crizanlizumab) as a new treatment option to prevent recurrent sickle cell crises in patients aged ≥16 Additionally, patients […]
Shots: The submission is based on the P-III ENSEMBLE 2 study that evaluates the booster dose COVID-19 vaccine in adults aged ≥18yrs with COVID-19 The […]
Shots: AstraZeneca has submitted a request to the US FDA seeking EUA for its AZD7442 to treatprophylaxis of symptomatic COVID-19. If EUA is granted, AZD7442 […]
Shots: ViiV Healthcare has reported a regulatory submission to the US FDA for the approval of a new dispersible tablet formulation of the fixed-dose combination […]
Shots: The approval was based on a P-I/II ZUMA-3 study assessing Tecartus in adult patients aged ≥18yrs. with ALL whose disease is refractory to or […]
Shots: The MAA was based on the efficacy & safety results from the P-II/III RELATIVITY-047 trial that evaluates the fixed-dose combination of relatlimab (160mg) + […]
Shots: The US FDA has granted premarket approval of TransMedics’s OCS liver system for use with organs from DBD and DCD. The approval is based […]
Shots: The approval was based on a clinical program including P-III ADVANCE study, P-IIb/III study & P-III LTS study evaluated the safety, efficacy & tolerability […]
Shots: The approval is based on P-III BEACON CRC trial evaluating Braftovi (300mg, qd) + Erbitux vs irinotecan + Erbitux or Folfiri + Erbitux in […]
Shots: The submission is based on clinical, biomarker & safety data of Study 201 POC study evaluates lecanemab (10mg/kg, q2w) in 856 patients with MCI […]
Shots: The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs […]
Shots: The approval is based on the two trials i.e., P-III Darvadstrocel-3002 & ADMIRE-CD trial evaluating the safety & efficacy of Alofisel in 22 & […]
Shots: The approval is based on the P-III EV-301 clinical trial evaluating Padcev vs CT in 608 patients with LA/mUC prior treated with Pt-based CT […]
Shots: The approval is based on the P-IIIb HAUSER-RCT study evaluating the safety & efficacy of Repatha (420mg, SC) vs PBO in a ratio (2:1) […]
The siloed approach to women’s healthcare is one of the main reasons the U.S. is unable to improve its record in this arena, according to […]
Shots: The NMPA has approved the IND application of SPR206 (IV) for the treatment of MDR gram-negative bacterial infections. Everest will initiate the clinical program […]
Shots: The US FDA has issued a EUA for the COVID-19 booster vaccine (administered at least 6mos. after completion of primary 2 doses) to prevent […]
Shots: The approval is based on the P-III REACH3 study evaluates the safety & efficacy of Jakafi vs BAT in patients ≥12yrs. with steroid-refractory chronic […]
Shots: The sNDA is based on the P-III ORIENT-15 clinical trial evaluates sintilimab + CT vs PBO + CT in a ratio (1:1) in 659 […]
Shots: The approval is based on the P-II innovaTV 204 clinical trials evaluating tisotumab vedotin in 101 patients with r/mCC who had received no more […]
Shots: The approval is based on the TRuE-AD clinical trial program which consists of two P-III studies i.e., TRuE-AD1 & 2 evaluating the safety and […]
Shots: The approval is based on a totality of evidence including analytical, non-clinical/clinical data from the P-III study evaluates the efficacy, safety, PK & immunogenicity […]
Shots: The approval is based on P-III COSMIC-311 evaluating Cabometyx (60mg, qd) vs PBO in a ratio (2:1) in 258 patients aged ≥12yrs. with radioactive […]
Shots: The application is based on 2 P-III U-ACHIEVE & U-ACCOMPLISH induction studies & 1 U-ACHIEVE maintenance study evaluating upadacitinib (45mg, qd) as IT & […]
Shots: The NICE recommendation is based on P-III APeX-2 trial evaluating Orladeyo vs PBO in adult & pediatric patients aged ≥12yrs. with HAE attacks The […]
Shots: The approval is based on 2 trials i.e., P-II MAGNOLIA & P-I/II BGB-3111-AU-003 trial evaluate Brukinsa (160mg, bid or 320 mg, qd) in 66 […]
Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C […]
Shots: The NMPA has granted BTD to amdizalisib for the treatment of r/r FL The preliminary results from the ongoing P-Ib expansion study showed that […]
Shots: The BLA submission is based on a P-III RATIONALE 302 trial evaluating the efficacy and safety of tislelizumab vs CT in 1972 patients with […]
Shots: The designation is based on the P-III EMPEROR-Preserved trial evaluates the safety and efficacy of empagliflozin (10mg, qd) vs PBO in 5,988 patients with […]
A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to […]
Shots: The approval is based on the P-III STOP 301 trial evaluates Trudhesa (0.725 mg/spray) in 5650+ patients with migraine with or without aura for […]
Shots: The approval is based on a RELIANCE study that evaluates efficacy & safety of relma-cel in 59 patients with r/r LBCL who had failed […]
Shots: TGA has provisionally approved the use of Moderna’s Spikevax (elasomeran) in individuals aged ≥12yrs. The decision follows the provisional approval granted by the TGA […]
Shots: NICE has recommended Cosentyx as a cost-effective option for the treatment of mod. to sev. PsO in patients aged 6-17 yrs. who have not […]
Shots: The approval is based on the P-III trial that evaluates Ultomiris (q4w/q8w) vs Soliris in children & adolescents aged ≤18yrs. with PNH The interim […]
Shots: The approval is based on a P-III study that evaluates Invega hafyera (q6mos., twice-yearly injectable) vs Invega trinza in 702 adults in a ratio […]
Shots: The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg, bid, or 320 mg, qd) vs ibrutinib in 201 patients with WM who […]
Shots: The US FDA has approved Merck’s Keytruda for the treatment of patients with locally advanced or mUC who are not eligible for any Pt-containing […]
Shots: The approval is based on the P-III heiGHt trial evaluating Skytrofa (qw) vs somatropin in 161 treatment-naïve children ≥aged 1yrs. with GHD who have […]
Shots: The conditional approval is based on the P-II L-MIND study evaluating the safety and efficacy of tafasitamab + lenalidomide in patients with r/r DLBCL […]
Shots: The sBLA is based on P-III trial for Comirnaty (third booster dose) administered b/w 4.8 – 8mos., following the completion of 2 dose in […]
Shots: The approval is based on P-III DAPA-CKD trial evaluate Forxiga (10mg, qd) + SoC vs PBO in 4304 patients with CKD Stage 2-4 & […]
Shots: The FDA has approved the Oncomine Dx target test as a CDx to identify patients with IDH1 mutated CCA who may be candidates for […]
Shots: The approval is based on the two P-III trials i.e., KALM-1, KALM-2 along with additional 32 clinical studies that evaluate Korsuva vs PBO in […]
Shots: The MAA is based on the P-III ADAPT trial evaluating the safety and efficacy of efgartigimod vs PBO in a ratio (1:1) in 167 […]
Shots: The approval is based on P-III CheckMate -9ER study evaluating ONO’s Opdivo (240 mg, IV, q2w) + Takeda’s Cabometyx (40mg, PO, qd) vs sunitinib […]
Shots: The approval is based on 3 P-III studies i.e., Measure Up 1/2/AD Up evaluating the efficacy & safety of Rinvoq (15/30 mg, qd) as […]
Shots: The approval is based on 3 P-III studies i.e., BE VIVID, BE READY, BE SURE evaluating the efficacy & safety of bimekizumab vs PBO […]
Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after […]
Shots: The DCGI has granted a EUA for ZyCoV-D which is the world’s first plasmid DNA vaccine for COVID-19. The company is planning to seek […]
Shots: The approval is based on a P-III study which includes 2 phases i.e., run-in & withdrawal phase evaluating efficacy & safety of tofacitinib (5mg […]
Shots: The sBLA is based on P-III RATIONALE 309 trial evaluating the efficacy & safety of tislelizumab + CT vs PBO + CT in a […]
Shots: The approval is based on the P-III CheckMate -274 trial evaluating Opdivo (240mg, IV, q2w, for ~1 yrs.) vs PBO in a ratio (1:1) […]
Shots: The FDA has approved the Ventana MMR RxDx Panel test as a CDx to identify patients with dMMR advanced solid tumors, who may be […]
Shots: The approval is based on the P-III program including 8 studies evaluating Evrenzo in 9600 patients with symptomatic anemia associated with CKD, regardless of […]
Shots: The MAA is based on the ongoing P-II/III CAPELLA study evaluates the antiviral activity of lenacapavir (PO, SC, every 6mos.) in combination with other […]
Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 106 CAR T cells) in […]
A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter […]
Shots: The approval is based on the P-III EMPEROR-Reduced trial evaluating the effect of Jardiance (10 mg, qd) vs PBO in 3730 adults with HFrEF […]
Shots: The conditional approval is based on the SIOPEN trial evaluating dinutuximab beta vs dinutuximab beta with/out IL-2 in 514 patients aged ≥12 mos. with […]
Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO […]
Shots: The approval is based on the results from cohort A1 & F of the ongoing P-I GARNET trial evaluates dostarlimab (500mg, IV, q3w for […]
Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a […]
Shots: The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo […]
Shots: The approval is based on two P-III international studies that evaluate cosentyx in pediatric patients aged 6 to <18 yrs. with mod. to sev. […]
Shots: The approval is based on P-III PRONTO-PUMP-2, a treat-to-target study that evaluates the efficacy & safety of Lyumjev (insulin lispro-aabc injection, 100 units/mL) vs […]
Shots: The initiation of a rolling submission to Health Canada for molnupiravir (bid, for 5 days) to treat COVID-19 is based on the P-II interim […]
Shots: The US FDA has approved Ticovac for active immunization to prevent TBE in patients aged ≥1 yrs. The US CDC’s will discuss recommendations regarding […]
Shots: The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC The FDA has provided recommendations to conduct […]
Shots: The approval is based on open-label study 004 trial evaluates welireg (120 mg, qd) in patients with VHL-associated tumors including RCC, CNS hemangioblastomas, or […]
Shots: The designation is based on the P-III JUPITER-02 trial evaluating toripalimab + CT vs CT alone in patients with NPC. The result was presented […]
Shots: The EUA is based on P-III study evaluating regdanvimab vs PBO in adults with COVID-19 who do not require supplemental oxygen & are at […]
Shots: The approval is based on the P-III withdrawal study that evaluates the efficacy and safety of Xywav (twice or once-nightly regimen, oral solution) vs […]
Shots: The US FDA has granted ODD to CFT7455 for the treatment of MM. The FDA grants ODD to drugs & biologics that are intended […]
Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima […]
Shots: The company has received an FDA’s CRL declining the approval of roxadustat’s NDA to treat anemia of CKD The FDA has requested to conduct […]
Shots: The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg, q3w) in 90 […]
Shots: The approval is based on P-III safety & efficacy study that evaluates Epidyolex (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive […]
Shots: The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs […]
Shots: The US FDA has granted FTD to selinexor (NOX inhibitor) for the treatment of PBC. Additionally, the therapy has previously received ODD for PBC […]
Shots: The approval is based on a P-III DAPA-CKD trial that evaluates the efficacy of Forxiga (10mg, qd in addition to SoC) vs PBO in […]
Shots: The approval is based on the P-III COMET trial that evaluates Nexviazyme (q2w, IV infusion) vs alglucosidase alfa in patients aged ≥1yrs. with LOPD […]
The UK’s Competition and Markets Authority (CMA) has resurrected a complaint against Pfizer and Flynn Pharma, claiming the two companies charged the NHS excessive prices […]
Shots: The priority review is based on P-III KEYNOTE-716 trial assessing Keytruda (anti-PD-1 therapy) vs PBO in 954 patients aged ≥12yrs. with stage II resected […]
Shots: The P-III DUBLIN-3 trial evaluates plinabulin + docetaxel vs docetaxel alone in 599 patients with 2L & 3L NSCLC EGFR wild type, with measurable […]
Shots: NICE has issued a final appraisal determination (FAD) which recommends UCB’s bimekizumab as a treatment option for adults with severe PsO The recommendation is […]
Shots: The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio […]
Shots: The approval is based on P-III UPTRAVI IV study evaluating the safety, tolerability, and PK of temporarily switching Uptravi (PO) to Uptravi (IV) in […]
Shots: The approval is based on efficacy and safety data from the clinical development program, including two P- III TULIP trials and the P-II MUSE […]
Shots: The approval is based on data from the SYNAPSE study evaluating mepolizumab vs PBO in ~400 patients with CRSwNP who had a history of […]
The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the […]
Shots: The BTD is based on early and preliminary clinical data involves assessing TAK-994 for the treatment of EDS that may demonstrated substantially improved objective […]
Shots: The BLA submission is based on four P-III studies i.e TENAYA, LUCERNE, YOSEMITE & RHINE evaluating the efficacy & safety of faricimab vs aflibercept […]
Shots: The CHMP’s positive opinion is based on P-III COMET study assessing avalglucosidase alfa that demonstrated improvements in respiratory function & movement endurance measures in […]
Shots: The approval is based on studies evaluating the safety & efficacy of Shingrix in adults aged ≥18yrs. who had undergone auHSCT and those undergoing […]
Shots: The approval is based on efficacy results from two studies. The P-II BGB-3111-206 study evaluates zanubrutinib in patients with R/R MCL and showed ORR […]
Shots: The US FDA has issued a CRL to the BLA of retifanlimab. The BLA submission is based on P-II POD1UM-202 trial assessing retifanlimab in […]
Shots: The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & […]
Shots: The approval is based on results of the P-III BCB114 trial evaluating Bydureon BCise (qw, injectable suspension) vs PBO in 82 patients aged b/w […]
Shots: The approval is based on P-III KEYNOTE-775/Study 309 trial evaluating Merck’s Keytruda (200mg, IV, q3w) + Eisai’s Lenvima (20mg, PO, qd) vs CT (doxorubicin, […]
Shots: The approval is based on P-II/III ALD-102 study evaluating Skysona in patients with an ABCD1 gene mutation aged <18 yrs. with CALD without matched […]
Shots: NMPA has granted approval to market infliximab biobetter in China. Sorrento holds exclusive commercial rights to Infliximab biobetter Ab outside of China and plans […]
Shots: The EC has approved Verquvo (2.5/5/10 mg) in the EU for the treatment of symptomatic CHF in adult patients with reduced ejection fraction who […]
Shots: The designation is based on interim results from the P-Ib M15-531 study evaluating Venclexta + azacitidine in naïve patients with previously untreated higher-risk MDS […]
Shots: The approval is based on P-III PEDFIC 1 & 2 studies evaluating Bylvay (qd) vs PBO in patients with pruritus in PFIC. The PEDFIC […]
Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 […]
Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently […]
Shots: The approval is based on KD025-213 study evaluating Rezurock (200 mg, qd) aged >12 yrs. in 65 patients with cGVHD who had received 2 […]
Shots: The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19 The results […]
Shots: The approval is based on P-III CASPIAN trial assessing Imfinzi + SoC (etoposide & carboplatin/ cisplatin CT) or Imfinzi + CT + tremelimumab vs […]
Shots: The US FDA has approved fexinidazole (PO, qd, 10days treatment) for both stages of Trypanosoma brucei gambiense form of sleeping sickness in patients aged […]
Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 […]
The UK’s competition authority has issued its largest ever fine of more than £260 million ($360 million) to several pharma companies accused of colluding to […]
Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that […]
The UK’s competition regulator has approved AstraZeneca’s $39 billion acquisition of US-based drugmaker Alexion, without opting for a broader inquiry into the deal. The nod […]
Shots: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with […]
Shots: The approval is based on P-III EV-301 trial evaluating Padcev vs CT in 608 patients with LA or mUC who were previously treated with […]
Shots: The approval is based on a P-III FIDELIO-DKD study evaluating finerenone (10/20mg) + SoC vs PBO + SoC in ~ 5700 patients with CKD […]
Shots: The FDA has granted FTD to LYS-GM101 for the Treatment of GM1 Gangliosidosis. The company has recently initiated an adaptative-design clinical trial evaluating the […]
Shots: The approval is based on the results from a P-III study that involves assessing Vyxeos (IV infusion) vs a current conventional treatment group in […]
Shots: The approval is based on P-III trial evaluating efficacy & safety of Kyprolis + dexamethasone in 123 patients with RRMM who have received at […]
Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) […]
Shots: The sBLA is based on P-III RATIONALE 302 trial evaluating efficacy & safety of tislelizumab vs CT as a 2L treatment in 512 patients […]
Shots: SciClone has submitted the BLA for Danyelza to treat pediatric patients aged >1 yr. and adult patients with r/r high-risk neuroblastoma to NMPA in […]
Shots: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients […]
Shots: The P-III ENSURE (1 &2) program evaluates IMU-838 (30mg, qd) vs PBO in ~ 1,050 patients with active RMS. The 1EPs of both trials […]
Shots: The approval is based on a P-III clinical trial that involves assessing Solosec (2g, PO, granules) vs PBO in 64 patients with trichomoniasis The […]
Shots: The NDA is based on two P-III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China. The anticipated PDUFA date is […]
Shots: The company has applied for emergency use authorization to the DCGI for ZyCoV-D, which is the world’s first plasmid DNA vaccine for COVID-19 Zydus […]
Shots: The US FDA has approved FoundationOne CDx to be used as a CDx for Alunbrig (brigatinib) which is approved for the treatment of adult […]
Shots: The approval is based on clinical data from an ongoing P-II/III JZP458-201 trial evaluating Rylaze in pediatric and adult patients aged ≥1mos. with ALL […]
Shots: Abbott has received approval in the US & and CE mark for XIENCE stents, the shortest approved DAPT labeling as short as 28 days […]
Shots: The US FDA has granted RPD and ODD to LX2006 for the treatment of FA. The company plans to start a P-I/II clinical trial […]
Shots: Formycon and Bioeq have submitted MAA for FYB201 (biosimilar referencing Lucentis) to EMA Teva will responsible for the commercialization of FYB201 in the EU […]
Shots: The full FDA approval is based on data from 2 clinical trials i.e., P-I EXPLORER & P-II PATHFINDER trial evaluating the efficacy of Ayvakit […]
Shots: The NDA is based on data from the BREEZE study evaluating Tyvaso DPI in 51 patients with PAH transitioning from Tyvaso inhalation solution which […]
Shots: The US FDA has approved the IND application of oral Asieris’ APL-1202 + BeiGene’s tislelizumab as neoadjuvant therapy in patients with MIBC The P-I/II […]
Shots: The US FDA has approved the NDA of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 […]
Shots: The approval is based on a P-III study evaluating the safety, PK & efficacy of Trikafta in 66 children aged 6-11yrs. old with CF […]
Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote […]
Shots: The approval is based in the clinical program including P-I & II trials, and three P-III trials evaluating the safety & immunogenicity of Prevnar […]
Shots: The approval is based on data from two P-III studies i.e SELECT-PsA 1 & 2 evaluating the safety & efficacy of Rinvoq vs PBO […]
Shots: The sBLA submission is based on results from a P-II study evaluating the efficacy & safety of tislelizumab (200 mg, IV, q3w) as monothx […]
Shots: Roche received a CE mark for its SARS-CoV-2 Ag self-test nasal at home setting for COVID 19. The test will be available in countries […]
Shots: The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of […]
Shots: The approval is based on the results from the P-IIIa STEP clinical trial program evaluating Wegovy (2.4mg injection, qw) in ~4,500 adults with obesity […]
Shots: The approval is based on the study assessing the effectiveness and safety of Ryplazim (every two to four days for 48 wks.) in 15 […]
Shots: The submission is based on data from the P-III PSOARING 1 & PSOARING as well as interim results from PSOARING 3 long-term safety study […]
Shots: The approval is based on P-III ORIENT-12 trial evaluating Tyvyt (sintilimab injection) or PBO + Gemzar (gemcitabine) & platinum CT in 357 patients in […]
Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w) vs CT in patients with […]
Shots: The FDA’s BT and EMA’s PRIME designations are based on data from the P-I MajesTEC-1 study evaluating the safety and efficacy of teclistamab (Ab […]
Shots: The approval is based on two P-III studies evaluating Cosentyx (75 mg/ 150 mg) vs PBO in children aged 6 to <18 yrs with […]
Shots: The approval is based on the P-III OLE trial involves assessing Nurtec ODT (rimegepant, 75 mg) vs PBO in patients with episodic migraine who […]
Shots: The conditional approval is based on the results of the P-II KarMMa study involves assessing Abecma in 122 patients with RRMM prior treated with […]
Shots: The NDA submission is based on data from the ongoing P-III MOVE trial evaluating the efficacy and safety of palovarotene (chronic/flare-up dosing regimen) in […]
Shots: The company has announced the resubmission of a label expansion application to the US FDA for the existing marketing authorization for Ozempic to introduce […]
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