Medical Device Network on MSN23h
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.
BEYONTTRA™ (acoramidis), the First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM
The approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in ...
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 ...
Med Device Online2d
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 ...
JD Supra4d
EU Biosimilar Regulatory and Launch Updates
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...
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 ...
Center for Biosimilars5d
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 ...