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 Equidacent (bevacizumab biosimilar), from… read more.
Glenmark announced Phase III results that showed its antiviral treatment favipiravir demonstrated a 28.6% faster viral clearance of COVID-19 compared to placebo . Favipiravir is a broad-spectrum oral… 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 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.
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.
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of Adakveo… read more.
Swedish Orphan Biovitrum AB (publ) (Sobi™) announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing… 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.
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.
Insmed announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending Arikayce (liposomal 590 mg nebuliser… read more.
UCB announced positive results from the Phase IIIb BE RADIANT study, a direct comparison of the investigational IL-17A and IL-17F inhibitor, bimekizumab, to the IL-17A inhibitor, Cosentyx (secukinumab)… read more.
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