Showing posts with label FDA approval. Show all posts
Showing posts with label FDA approval. Show all posts
Tuesday, July 28, 2026

FDA Approves Komzifti (ziftomenib) for the Treatment of Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

›
Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151)  announced the U.S. Food and Drug Administration (FDA)   approval o...
Friday, July 24, 2026

FDA Approves Cardamyst (etripamil) Nasal Spray for Adults with Paroxysmal Supraventricular Tachycardia

›
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced  the U.S. Food and Drug Administration (FDA) approved its first commercial product, ...
Thursday, July 23, 2026

FDA Approves Nuzolvence (zoliflodacin) for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents

›
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA),   announced   the U.S. Food and Drug Administration (FDA)  a...
Wednesday, July 22, 2026

FDA Approves Myqorzo (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

›
Cytokinetics, Incorporated (Nasdaq: CYTK) announced the U.S. Food and Drug Administration (FDA) approval of  Myqorzo™ (aficamten, 5 mg, 10 m...
Tuesday, July 21, 2026

FDA Approves Aqvesme (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

›
Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for pati...
Tuesday, June 2, 2026

FDA Approves Clotic (clotrimazole otic solution), First Treatment with Clinical Evidence for Fungal Ear Infections

›
In continuation of my update on  clotrimazole Laboratorios Salvat, S.A. ("Salvat") announced today that the U.S. Food and Drug Adm...
Wednesday, February 18, 2026

FDA Approves Linzess (linaclotide) for Children 7 Years and Older with Irritable Bowel Syndrome with Constipation

›
The U.S. Food and Drug Administration (FDA) has approved Linzess (linaclotide) capsules for pediatric patients 7 years and older with irrita...
Monday, February 16, 2026

FDA Approves Caplyta (lumateperone) as an Adjunctive Therapy for the Treatment of Major Depressive Disorder (MDD) in Adults

›
In continuation of my update on lumateperone Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) approva...
Friday, February 13, 2026

FDA Approves Zoryve for Atopic Dermatitis in Young Children

›
In continuation of my update on Zoryve The U.S. Food and Drug Administration has approved the supplemental new drug application for Zoryve (...
Saturday, January 31, 2026

FDA Approves Kygevvi (doxecitine and doxribtimine) for the Treatment of Thymidine Kinase 2 Deficiency

›
UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Kygevvi has been granted approval by the U.S. Food an...
Friday, January 30, 2026

FDA Approves Epioxa (riboflavin 5’-phosphate) Ophthalmic Solution for the Treatment of Keratoconus

›
Glaukos Corporation, an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, c...
Thursday, January 29, 2026

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

›
In Continuation of my update on fosfomycin The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for t...
Wednesday, January 28, 2026

FDA Approves Contepo (fosfomycin) for Injection for the Treatment of Complicated Urinary Tract Infections

›
The U.S. Food and Drug Administration (FDA) has approved Contepo (fosfomycin) for injection for the treatment of patients 18 years of age an...