July 24, 2020
The first-in-class drug belantamab mafodotin (Blenrep, GlaxoSmithKline) has been recommended for conditional marketing approval in the European Union (EU) for use in the treatment of relapsed […]
July 23, 2020
A skin patch that delivers an 8% capsaicin formulation intradermally and that first received US Food and Drug Administration approval in 2009 for the treatment of […]
July 22, 2020
The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy […]
July 22, 2020
The US Food and Drug Administration (FDA) has approved Boston Scientific’s WATCHMAN FLX transcatheter left atrial appendage (LAA) occluder device as an alternative to oral anticoagulation […]
July 15, 2020
The US Food and Drug Administration (FDA) has approved an aortic-valved conduit (KONECT RESILIA, Edwards Lifesciences) for bio-Bentall procedures, the company announced today. “Until now, surgeons […]
June 30, 2020
The US Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or […]
June 29, 2020
The US Food and Drug Administration approved a combination of pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche) that is administered subcutaneously — rather […]
June 29, 2020
The US Food and Drug Administration (FDA) has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously […]
June 26, 2020
The US Food and Drug Administration (FDA) has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with […]