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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 […]
June 29, 2020

FDA Approves First Oral Somatostatin Analog for Acromegaly FDA Approves First Oral Somatostatin Analog for Acromegaly

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

FDA Okays New Treatment for Dravet Syndrome FDA Okays New Treatment for Dravet Syndrome

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 […]
June 24, 2020

FDA Approves Metoclopramide Nasal Spray for Diabetic Gastroparesis FDA Approves Metoclopramide Nasal Spray for Diabetic Gastroparesis

The Food and Drug Administration has approved a new formulation of metoclopramide for relief of symptoms of diabetic gastroparesis in adults. The product, called Gimoti (Evoke […]
June 22, 2020

FDA OKs Implantable Neurostimulator for Intractable Low Back Pain FDA OKs Implantable Neurostimulator for Intractable Low Back Pain

The US Food and Drug Administration (FDA) has approved an implantable neurostimulation system (ReActiv8, Mainstay Medical) to treat intractable chronic low back pain associated with multifidus […]
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