EMA establish advisory portal for high-risk medical devices
The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.
Moleculin Announces First European Approval for Phase 3 AML Trial
HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company currently trading near its 52-week low of $0.66, announced it has received the first European regulatory approval ...
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BEYONTTRA™ (acoramidis), the First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM
1 Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA ...
Regeneron Pharmaceuticals, Inc.: Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.