FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

December 01, 2020 -- Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membr

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FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commerciali

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FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

BOSTON, Nov. 27, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic di

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FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 24, 2020 -- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA)

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FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

PALO ALTO, Calif., Nov. 20, 2020 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare di

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FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation

BRAINTREE, Mass., Nov. 10, 2020 /PRNewswire/ -- Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassi

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FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

PAOLI, Pa., -- (BUSINESS WIRE) -- November 9, 2020 -- Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium fo

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FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food

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FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease

WATERTOWN, Mass.--(BUSINESS WIRE)--Oct. 27, 2020 -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative ther

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FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

FOSTER CITY, Calif.--(BUSINESS WIRE) - Oct. 22, 2020 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (r

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FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

TARRYTOWN, N.Y., Oct. 14, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab

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FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency

DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rar

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