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Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...
ophthalmologytimes1d
CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
FiercePharma4d
Merck vaccine, Daiichi ADC win approval recommendations in busy week at EU's drug regulator
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
J&J gets positive EU opinion for subcutaneous Rybrevant
EU regulators have issued a positive opinion for the extension of the market authorization for subcutaneous formulation of ...
NL Times11d
European Medicines Agency ditches Elon Musk’s X in favor of Bluesky
The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...
Ocugen gets positive EU opinion for ATMP classification for OCU400
Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...
AstraZeneca’s Imfinzi recommended for approval in EU by CHMP
Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...
Pharmabiz1d
Bayer seeks European marketing approval for use of finerenone in adult patients with HF with a left ventricular ejection fraction (LVEF) of =40%
Bayer seeks European marketing approval for use of finerenone in adult patients with HF with a left ventricular ejection fraction (LVEF) of =40%: Berlin Tuesday, February 4, 2025, ...