Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively ...
MUNICH, Germany, and BASILDON, UK I February 13, 2025 I LINDIS Biotech GmbH, a clinical stage biopharmaceutical company with a proprietary multi-specific ...
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) ...
Under the terms of the deal, Bedford, Mass.-based Stoke (STOK) will retain exclusive rights for the treatment called zorevunersen in the U.S., Canada and Mexico, while Cambridge, Mass.-based Biogen ...
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
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 ...
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
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GlobalData on MSNEMA establish advisory portal for high-risk medical devicesThe EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.
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 ...
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
On 20 December 2021, the EU authorised the first protein-based vaccine (produced by Novavax) for use in the EU, following a positive recommendation of the European Medicines Agency. The Novavax ...
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