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.
manilatimes1d
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.
manilatimes1d
ParaZero Achieves Regulatory Compliance in Europe to Fly in Urban Environments with its SafeAir Systems
With the CE Class C5 certification in place, ParaZero is well-positioned to support drone operators across Europe in meeting regulatory requirements, unlocking new business opportunities in industries ...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
TD Cowen cuts Merck stock rating, price target to $100
TD Cowen made a significant adjustment to its stance on Merck (NSE:PROR) shares, downgrading the pharmaceutical giant from "Buy" to "Hold". Accompanying the downgrade, the firm also revised its price ...
Med Device Online3d
PMS And Supply Chain Visibility For EU Compliance
One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR ...
Fact Check: Moderna began clinical trials of COVID vaccine in 2020, not 2017
Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...
CSL Behring confirms long-term efficacy of HEMGENIX in hemophilia B treatment
Global biotechnology leader CSL Behring (ASX:CSL; USOTC: CSLLY (OTC:CSLLY)) announced the four-year results from the HOPE-B ...
centerforbiosimilars6d
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...