scPharmaceuticals Inc. announced that the FDA has accepted for review the company’s New Drug Application (NDA) resubmission for Furoscix. scPharmaceuticals is developing Furoscix a proprietary, subcutaneously delivered furosemide… read more.
Imfinzi (durvalumab) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination… read more.
Moderna announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Calquence (acalabrutinib), from AstraZeneca,… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zynrelef (bupivacaine and meloxicam),… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Equidacent (bevacizumab biosimilar), from… read more.
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Ayvakyt (avapritinib), from Blueprint… read more.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of GSK 2857916 (belantamab mafodotin), from… read more.
Gilead Sciences, Inc.and Galapagos NV announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca (filgotinib 200… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion… read more.
Kite Pharma/Gilead Sciences announced that the FDA has granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell… read more.
Kyowa Kirin announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the expanded approval of Crysvita (burosumab) to… read more.
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