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 ...
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WHO identifies research priorities for boosting fight against antimicrobial resistance
The global research agenda includes 33 research priorities for bacterial and fungal infections and 7 for drug-resistant ...
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FDA approves combination antibiotic for difficult-to-treat infections
Emblaveo (aztreonam-avibactam) was approved for treating complicated intra-abdominal infections with limited or no treatment ...
CVM: Fiscal Year 2024 Results
CVM READ THE FULL CVM RESEARCH REPORT CEL-SCI Corporation (NYSE:CVM) reports fiscal year 2024 financial and operational ...
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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 ...
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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 ...