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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 […]
June 19, 2020

FDA Gives Thumbs Up to Tazemetostat for Follicular Lymphoma FDA Gives Thumbs Up to Tazemetostat for Follicular Lymphoma

The US Food and Drug Administration (FDA) has granted accelerated approval of the EZH2 inhibitor tazemetostat (Tazverik, Epizyme, Inc) for the treatment of relapsed or refractory […]
June 19, 2020

FDA Approves First Drug for Adult-Onset Still’s Disease FDA Approves First Drug for Adult-Onset Still’s Disease

The Food and Drug Administration has expanded the indications for canakinumab (Ilaris) to include all patients with active Still’s disease older than 2 years, adding adult-onset […]
June 18, 2020

FDA Approves Cosentyx for Treatment of Active nr-axSpA FDA Approves Cosentyx for Treatment of Active nr-axSpA

The Food and Drug Administration has approved secukinumab (Cosentyx) for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA), according to an announcement from the drug’s manufacturer, Novartis. FDA approval was […]
June 18, 2020

FDA Approves Lilly’s Ultra-Rapid-Acting Insulin, Lyumjev FDA Approves Lilly’s Ultra-Rapid-Acting Insulin, Lyumjev

The US Food and Drug Administration has approved rapid-acting insulin lispro-aabc injection 100 and 200 units/mL (Lyumjev, Eli Lilly) for the treatment of adults with type […]
June 16, 2020

FDA Approves Video Game-Based Therapy for Kids With ADHD FDA Approves Video Game-Based Therapy for Kids With ADHD

The US Food and Drug Administration (FDA) has allowed marketing of a “prescription-only game-based” digital therapeutic device for children aged 8 to 12 years who have […]
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