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.
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.
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.
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.
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.
AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The approval by the FDA… read more.
BioMarin Pharmaceutical Inc. announced that the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for vosoritide, an investigational, once daily injection analog of… read more.
G1 Therapeutics, Inc. a clinical-stage oncology company, announced a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for… read more.
CymaBay Therapeutics announced that the FDA lifted clinical holds on seladelpar for all three Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and… read more.
Acadia Pharmaceuticals Inc. announced top-line results from its 298 patient Phase III CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of… read more.
Genentech, a member of the Roche Group announced detailed results from the Phase III Archway study evaluating its investigational Port Delivery System with ranibizumab (PDS) for the treatment… read more.
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