Wednesday, February 13, 2019

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma

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In continuation of my update on  Cabometyx (cabozantinib) Exelixis, Inc. announced that the U.S. Food and Drug Administration (F...
Tuesday, February 12, 2019

FDA Approves Tosymra (sumatriptan) Nasal Spray for Acute Treatment of Migraine

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In continuation of my update on  Tosymra (sumatriptan) Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC today ann...
Saturday, February 9, 2019

FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia

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In continuation of my update on    ibrutinib The Janssen Pharmaceutical Companies of Johnson & Johnson announced  the U.S. Foo...
Friday, February 8, 2019

FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause

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Duchesnay Inc., a pharmaceutical company specializing in women’s health, announced   that the FDA has approved its supplemental New Drug A...
Friday, February 1, 2019

New One-Dose Flu Drug Shows Promise

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An experimental single-dose  flu  drug shows promise as a new way to alleviate the misery of  influenza , researchers say.  The drug...
Wednesday, January 30, 2019

FDA Approves New Indication for Envarsus XR (tacrolimus extended-release tablets)

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In continuation of my update on Tacrolimus Veloxis Pharmaceuticals announced today that the U.S. Food & Drug Administration (FDA...
Saturday, January 26, 2019

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)

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SHPG) has announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity (prucalopride), a once-daily, oral treat...

FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management

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       Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, announced that the U.S. Food and D...
Friday, January 25, 2019

Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer

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In continuation of my update on  olaparib AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada)  anno...

Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA

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Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administra...

Experimental drug can protect against Ebola in a single dose

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Dr. Thomas Geisbert, a world-renowned Ebola researcher at The University of Texas Medical Branch, said that previous therapeutics typica...
Thursday, January 24, 2019

FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections

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In continuation of my update on Itraconazole Mayne Pharma Group Limited (ASX: MYX) announced,  that the US Food and Drug Administr...
Wednesday, January 23, 2019

FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome

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The U.S. Food and Drug Administration,  approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (...
Tuesday, January 22, 2019

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery

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In continuation of my update on  Dexamethasone Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation,...
Saturday, January 19, 2019

FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns

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  In  continuation of my update on   glycerol phenyl butyrate            Horizon Pharma plc (NASDAQ: HZNP) announced the U.S. Food and ...