Showing posts with label FDA Approves. Show all posts
Showing posts with label FDA Approves. Show all posts
Friday, May 29, 2026

FDA Approves Rhapsido (remibrutinib) for the Treatment of Chronic Spontaneous Urticaria

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Novartis announced today that Rhapsido (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult...
Wednesday, May 27, 2026

FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions

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Eli Lilly and Company (NYSE: LLY)  announced the FDA approval of   Foundayo™ (orforglipron) for adults with obesity, or overweight with weig...
Wednesday, May 20, 2026

FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis

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Boehringer Ingelheim’s Jascayd (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) as an oral treatment...
Thursday, May 14, 2026

FDA Approves Ferabright (ferumoxytol injection) Contrast Agent for Magnetic Resonance Imaging of the Brain

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Azurity Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ferabright (ferumoxytol injection), the fi...
Tuesday, October 8, 2024

FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

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Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA...
Monday, October 7, 2024

FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

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Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayr...
Saturday, October 5, 2024

FDA Approves Sofdra (sofpironium) Topical Gel for the Treatment of Primary Axillary Hyperhidrosis

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Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Ad...
Friday, October 4, 2024

FDA Approves Vigafyde (vigabatrin) as the First and Only Ready-to-Use Vigabatrin Oral Solution

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Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, ann...
Wednesday, October 2, 2024

FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy

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Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue dete...
Tuesday, October 1, 2024

FDA Approves Xromi (hydroxyurea) Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia

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The U.S. Food and Drug Administration (FDA) has approved Xromi, an oral solution formulation of hydroxyurea indicated to reduce the frequenc...
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...
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...