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July 24, 2020

FDA Okays New CAR T Therapy, First for Mantle Cell Lymphoma FDA Okays New CAR T Therapy, First for Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) today granted accelerated approval to brexucabtagene autoleucel (Tecartus, Kite Pharma), the first approved chimeric antigen receptor (CAR) T cell therapy for […]
July 24, 2020

CHMP Backs Bupivacaine/Meloxicam (Zynrelef) for Postop Pain CHMP Backs Bupivacaine/Meloxicam (Zynrelef) for Postop Pain

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the fixed-dose combination of bupivacaine and meloxicam […]
July 24, 2020

EU Gives Thumb Up for Belantamab in R/R Multiple Myeloma EU Gives Thumb Up for Belantamab in R/R Multiple Myeloma

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

FDA OKs Capsaicin Patch for Diabetic Neuropathy Foot Pain FDA OKs Capsaicin Patch for Diabetic Neuropathy Foot Pain

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

FDA Okays Low-Sodium Treatment Option for Narcolepsy FDA Okays Low-Sodium Treatment Option for Narcolepsy

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

FDA Approves WATCHMAN FLX for Stroke Reduction by LAA Occlusion FDA Approves WATCHMAN FLX for Stroke Reduction by LAA Occlusion

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

FDA Clears Edwards’ KONECT RESILIA Aortic-Valved Conduit FDA Clears Edwards’ KONECT RESILIA Aortic-Valved Conduit

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

Pembro Approved for 1st-Line Use in MSI-H/dMMR Colorectal Cancer Pembro Approved for 1st-Line Use in MSI-H/dMMR Colorectal Cancer

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

FDA Approves In-home Breast Cancer Treatment FDA Approves In-home Breast Cancer Treatment

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 […]
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