Thursday, October 3, 2019

FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer

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U.S. Food and Drug Administration approved   Piqray   (alpelisib) tablets, to be used in combination with the FDA-approved endocrine...
Wednesday, October 2, 2019

FDA Approves Jakafi (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease

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In continuation of my update  on  ruxolitinib Incyte Corporation   announced that the U.S. Food and Drug Administration (FDA...
Tuesday, October 1, 2019

Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

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In continuation of my update on  Dextenza   Ocular Therapeutix™, Inc. ), a biopharmaceutical company focused on the formulation, develop...
Saturday, September 28, 2019

AMAG Pharmaceuticals Announces FDA Approval of Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women

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In continuation of my update on   bremelanotide MAG Pharmaceuticals, Inc.    announced  that the U.S. Food and Drug Administrati...
Friday, September 27, 2019

FDA Approves Expanded Use of Vraylar (cariprazine) in the Treatment of Bipolar Depression

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In continuation of my update on Cariprazine Allergan plc (NYSE: AGN) and Gedeon Richter Plc.   announced that the U.S. Food and Drug A...
Thursday, September 26, 2019

FDA Approves Zerbaxa (ceftolozane and tazobactam) 3g Dose for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

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                Ceftolozane/tazobactam                                                           Tazobactam                           ...
Wednesday, September 25, 2019

FDA Approves Expanded Use of Vraylar (cariprazine) in the Treatment of Bipolar Depression

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In continuation of my update on   VRAYLAR  ( cariprazine ) Allergan plc (NYSE: AGN) and Gedeon Richter Plc.   announced that the U.S...
Tuesday, September 24, 2019

PTC Therapeutics Receives FDA Approval for the Expansion of the Emflaza (deflazacort) Labeling to Include Patients 2-5 Years of Age

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     PTC Therapeutics, Inc. (NASDAQ: PTCT)   announced that the U.S. Food and Drug Administration (FDA) approved the company's s...
Tuesday, August 20, 2019

FDA Approves Wakix (pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy

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Harmony Biosciences, LLC (Harmony) announced the U.S. Food and Drug Administration (FDA) approval of Wakix (pitolisant) for the treatm...
Thursday, August 15, 2019

FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)

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In continuation of my update on tofacitinib  The U.S. Food and Drug Administration has approved new warnings about an increased risk o...