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 ...
manilatimes19h
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Linvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and ...
Daily1d
Bayer files for approval of extended 6 month treatment interval for Eylea 8 mg in EU
Berlin: Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 ...
cidrap.umn1d
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 ...
cidrap.umn1d
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 ...
Taiwan News2d
Santhera Announces Chief Financial Officer Transition with Appointment of Catherine Isted
Current CFO Andrew Smith to step down after five years with Santhera, and will support an orderly transition ...
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 ...
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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 ...