Monday, September 30, 2024

FDA Approves Rytelo (imetelstat) for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia

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Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer...
Saturday, September 28, 2024

FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma

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Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to deve...
Friday, September 27, 2024

FDA Approves Onyda XR (clonidine hydrochloride) Non-Stimulant Liquid Treatment for ADHD

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Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, add...
Thursday, September 26, 2024

FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia

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Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has au...
Wednesday, September 25, 2024

FDA Approves Zevtera (ceftobiprole medocaril sodium) for Bacteremia, Skin and Skin Structure Infections, and Pneumonia

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Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients wi...
Tuesday, September 24, 2024

FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection

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Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the need...
Monday, September 23, 2024

FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years

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Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful...
Saturday, September 21, 2024

FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections

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Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated ur...
Friday, September 20, 2024

FDA Approves Voydeya (danicopan) as Add-On Therapy for the Treatment of Extravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuria

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Voydeya   (danicopan) has been approved in the US as an add-on therapy to eculizumab or eculizumab for the treatment of extravascular hemoly...
Wednesday, September 18, 2024

FDA Approves Vafseo (vadadustat) for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

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Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney dise...
Tuesday, September 17, 2024

FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy

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Italfarmaco S.p.A.  announced today that the  U.S. Food and Drug Administration (FDA)  has approved Duvyzat™ (givinostat), a novel histone d...
Monday, September 16, 2024

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

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Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi ®  – a single-tablet combination...
Friday, September 13, 2024

FDA Approves Rezenopy (naloxone hydrochloride) Nasal Spray for the Emergency Treatment of Opioid Overdose

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The U.S. Food and Drug Administration has approved Rezenopy (naloxone hydrochloride) nasal spray 10 mg for emergency treatment of known or s...
Thursday, September 12, 2024

FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension

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Idorsia Pharmaceuticals U.S. Inc. announced the US Food and Drug Administration (FDA) approval of  Tryvio™ (aprocitentan) for the treatment ...