Roche’s fast-growing eye drug Vabysmo set for EU approval
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the […]
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the […]
PTC Therapeutic’s Upstaza gene therapy for patients with genetic disorder AADC deficiency has been recommended for approval in the EU, setting up another test of […]
Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – […]
Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it […]
A new treatment for adults with insomnia disorder has been recommended for use in Europe, giving hope to people whose lives are blighted by the […]
The EMA’s human medicines committee has said it cannot approve Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, saying it was unconvinced by the data submitted […]
Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s drug Aduhelm when it comes up for […]
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 […]
Danish drugmaker Novo Nordisk is hoping to launch its once-weekly injectable treatment for obesity, Wegovy, in the EU next year after getting a green light […]
The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to […]
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 […]
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 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 […]
The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or […]
Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after […]
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 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 CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no […]
Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal […]
US biotech bluebird bio has had a challenging time in the last few months, so a recommendation for EU approval of its gene therapy for […]
Shots: The recommendation is based P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC […]
Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum […]
Roche’s Enspryng has been recommended for approval in the EU for treating neuromyelitis optica spectrum disorder (NMOSD), extending the treatment options for people with the […]
Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 […]
Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with […]
The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab […]
Shots: EMA’s CHMP has adopted a positive opinion recommending the use of Benlysta (IV, SC) in combination with background immunosuppressive therapies for the treatment of […]
The EU’s medicines regulator has recommended granting conditional approval to a fourth COVID-19 vaccine – a single-dose shot from Johnson & Johnson’s Janssen unit – […]
The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, […]
Shots: The CHMP has adopted a positive opinion recommending the marketing authorization of Abevmy (inj. bevacizumab 100 & 400mg), which is co-developed by Biocon and […]
Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced […]
Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who […]
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 […]
Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company […]
Shots: The EMA’s CHMP has adopted a positive opinion of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with documented […]
Novartis’ multiple sclerosis drug has been given the green light by the European Medicines Agency’s CHMP scientific committee, paving the way for a likely approval […]
Shots: The EMA’s CHMP accepted a positive opinion for the use of Sogroya (somapacitan), once-weekly recommending its approval for the treatment of adults with growth […]
The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that […]
Shots: AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, […]
Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine […]
Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which […]
The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s […]
Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere […]
Gilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for cancer, after the CHMP backed its Tecartus […]
Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma […]
Shots: The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran […]
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 […]
Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of […]
GlaxoSmithKline is closing in on EU approval for its first-in-class BCMA-targeting drug Blenrep, after getting a green light from the EMA’s human medicines committee. Blenrep, […]
Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three […]
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