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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 ...
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 ...
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 ...
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 ...
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 ...
European Commission nods at Ocugen's gene therapy
MALVERN, Pa. - Ocugen, Inc. (NASDAQ: NASDAQ:OCGN), a biotechnology company with a current market capitalization of $212 million, announced today that the European Commission has endorsed the European ...
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 ...
Medscape4d
EMA Recommends Approval of Capvaxive Pneumococcal Vaccine
The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...