Showing posts with label FDA Approves. Show all posts
Showing posts with label FDA Approves. Show all posts
Friday, April 9, 2021

FDA Approves Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma

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In continuation of my update on  Tivozanib AVEO Oncology (Nasdaq: AVEO)   announced  the U.S. Food and Drug Administration (FDA)   approval ...
Thursday, April 8, 2021

FDA Approves Kimyrsa (oritavancin) for the Treatment of Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

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Melinta Therapeutics, LLC (Melinta), a commercial-stage company focused on the development and commercialization of novel antibiotics, today...
Monday, February 8, 2021

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB)

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Urovant Sciences (Nasdaq: UROV) announced    the U.S. Food and Drug Administration (FDA)  approval of  the New Drug Application (NDA) for on...
Saturday, February 6, 2021

FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients

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BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX)  announced the U.S. Food and Drug Administration (FDA) approval of  oral, once-daily Orladeyo ...
Thursday, January 21, 2021

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

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Sebela Pharmaceuticals®  announced  the U.S. Food and Drug Administration (FDA) approval of  Sutab® (sodium sulfate, magnesium sulfate, and ...
Friday, January 8, 2021

FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair

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In continuation of my update on bupivacaine  Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet ...
Thursday, January 7, 2021

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne

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Cassiopea SpA (SIX: SKIN),  announced   the United States Food and Drug Administration (FDA) approval of  Winlevi (clascoterone cream 1%) fo...
Friday, November 13, 2020

FDA Approves Durysta (bimatoprost implant) to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients

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Allergan plc (NYSE: AGN), a leading global pharmaceutical company with more than 70 years of heritage in eye care, announced the U.S. Food a...
Thursday, April 23, 2020

FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma

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Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies,  announced that the U.S. Food...
Wednesday, April 22, 2020

FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in Adults

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In continuation of my update on  empagliflozin / linagliptin / metformin         The U.S. Food and Drug Administration (FDA) h...
Saturday, January 11, 2020

FDA Approves Otezla (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

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In continuation of my update on  Otezla (apremilast)  Celgene Corporation today announced that the U.S. Food and Drug Administration...
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...
Friday, June 28, 2019

FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome

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In continuation of my update on  amifampridine The U.S. Food and Drug Administration approved Ruzurgi (amifampridine) tablets for ...