The EU regulates the authorisation of medicines at EU level by the European Medicines Agency or at national level by the competent authorities in EU countries. Special rules exist for the ...
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EU reshapes HTAs: is the industry ready for it?New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
CSL (CSLLY) and Arcturus Therapeutics (ARCT) announced that the European Commission has granted marketing authorization for Kostaive, a ...
Galapagos is dropping its junior CD19 CAR-T as part of the Belgian biotech’s seemingly never-ending mission to recalibrate ...
Researchers at the LKS Faculty of Medicine of the University of Hong Kong (HKUMed) have invented an oral formulation of ...
Anavex Life Sciences Corp. expects feedback from the European Medicines Agency on blarcamesine for Alzheimer's Disease this ...
Gilead Sciences, Inc. ( NASDAQ: GILD) Q4 2024 Earnings Conference Call February 11, 2025 4:30 PM ET Jacquie Ross - SVP, Treasury & IR Daniel O'Day - Chairman, CEO Johanna Mercier - Chief Commercial ...
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EMA establish advisory portal for high-risk medical devicesThe EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.
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Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
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