Showing posts with label approval. Show all posts
Showing posts with label approval. Show all posts
Wednesday, August 13, 2025

FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

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In continuation of my update on  lisdexamfetamine Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Arynta™ (lisd...
Tuesday, August 12, 2025

FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria

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In continuation of my update on  nitisinone Cycle Pharmaceuticals has announced   the FDA approval of  Harliku (nitisinone) Tablets for the ...
Friday, July 25, 2025

FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer

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Nuvation Bio Inc. announced the U.S. Food and Drug Administration (FDA)  approval of  Ibtrozi (taletrectinib) for the treatment of adult pat...
Saturday, June 14, 2025

FDA Approves Mezofy (aripiprazole) Oral Film for the Treatment of Schizophrenia

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In continuation of my update on Aripiprazole CMG Pharmaceuticals, an affiliate of Cha Biotech, announced on the 16th that it had received pr...
Thursday, June 12, 2025

FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine

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Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395),  announced  the U.S. Food and Drug Administration (FDA) approval of    New Drug Applic...
Monday, January 24, 2022

FDA Approves Apretude

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  ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Lim...
Thursday, November 19, 2020

FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis

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Myers Squibb Company (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) approved  Zeposia  (ozanimod) 0.92 mg for the t...
Friday, November 13, 2020

FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease

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The U.S. Food and Drug Administration today approved  Isturisa  (osilodrostat) oral tablets for adults with Cushing’s disease who either can...
Tuesday, December 24, 2019

Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline Depot (lanreotide)

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  Ipsen Biopharmaceuticals, an affiliate of Ipsen , announced today that the United States Food and Drug Administration (FDA) has appr...
Wednesday, July 3, 2019

FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients

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The U.S. Food and Drug Administration today approved Mavyret (telaprevir and pibrentasvir) tablets to treat all six genotypes of hepatit...
Tuesday, July 2, 2019

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

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In continuation of my update on  dapagliflozin , and metformin hydrochloride   Dapagliflozin               Saxagliptin    ...
Saturday, April 27, 2019

FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism

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  The U.S. Food and Drug Administration  approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certa...
Thursday, April 25, 2019

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression

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   In continuation of my update on  esketamine The U.S. Food and Drug Administration   approved   Spravato   (esketamine) nasal sp...