Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms…
Otsuka Pharmaceutical Europe Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced that the European Commission (EC) has approved Abilify Maintena® 960 mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI) formulation for the maintenance treatment of schizophrenia in adult patients…
Merck, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial…
Ultomiris (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval by the US…
AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up…
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Fabhalta® (iptacopan) for the treatment of adults with paroxysmal…
The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic…
Bristol Myers Squibb today announced that the European Commission (EC) has granted approval to Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory…
Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has approved SPEVIGO® (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg. This approval follows the Chinese…
Roche announced today that the FDA has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with…