MHRA submission follows EMA validation of the VIZZ MAA in March 2026Sixth ex-U.S. regulatory submission for VIZZ underscores accelerating global ...

STOCKHOLM, May 22, 2023 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that they have submitted a Marketing Authorisation Application (MAA) for ...

TOKYO and NEW YORK, March 26, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in ...

The Ministry of Health has set a 180-working-day review period for the MAA - - MAA process is one step in planned expansion of Symvess into ...

On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) ...

Eisai submitted a marketing authorization application for Leqembi, the Alzheimer’s drug jointly developed with Biogen, to the European Medicines Agency, the company announced late Tuesday afternoon.

Please provide your email address to receive an email when new articles are posted on . Krystal Biotech submitted a marketing authorization application to the European Medicines Agency for dystrophic ...

Please provide your email address to receive an email when new articles are posted on . The European Medicines Agency accepted the marketing authorization application for avacincaptad pegol. Next, the ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”), today announced that its Marketing Authorisation ...

Additional filings are planned for the U.K., Canada and other regions included in Eisai's licensed territories Taletrectinib is already approved in the U.S., China and Japan for advanced ROS1-positive ...