Friday, December 19, 2025

FDA Approves KETARx (ketamine) for Surgical Pain Management

›
PharmaTher Holdings Ltd. announced     the U.S. Food and Drug Administration (FDA) approval of  KETARx™, on August 8th, 2025, for its indica...
Tuesday, December 16, 2025

FDA Grants Accelerated Approval to Hernexeos (zongertinib) for Previously Treated Patients with HER2-Mutant Advanced NSCLC

›
Boehringer Ingelheim’s Hernexeos (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibito...
Monday, December 15, 2025

FDA Grants Accelerated Approval to Modeyso (dordaviprone) for the Treatment of Recurrent H3 K27M-Mutant Diffuse Midline Glioma

›
Jazz Pharmaceuticals plc (Nasdaq: JAZZ)  announced the U.S. Food and Drug Administration (FDA) accelerated approval of  Modeyso (dordavipron...
Saturday, December 13, 2025

FDA Approves Vostally (ramipril) Oral Solution for the Treatment of Hypertension in Adults

›
Rosemont Pharmaceuticals, Inc. announced  the U.S. Food and Drug Administration (FDA)  approval of  Vostally (ramipril) Oral Solution, an an...
Wednesday, December 10, 2025

FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria

›
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced   U.S. Food and Drug Administration (FDA)  approval of Sephience™ (sepiapterin) for the trea...
Tuesday, December 9, 2025

FDA Approves Enbumyst (bumetanide) Nasal Spray for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease

›
Corstasis Therapeutics Inc., announced the U.S. Food and Drug Administration (FDA)  approval of  Enbumyst (bumetanide nasal spray). Enbumyst...
Monday, December 8, 2025

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

›
In continuation of my update on Nitisinone Cycle Pharmaceuticals announced the FDA approval of  Harliku (nitisinone) Tablets for the reducti...
Friday, December 5, 2025

FDA Approves Yeztugo (lenacapavir) as the First and Only HIV Prevention Option Offering 6 Months of Protection

›
In continuation of my update  lenacapavir Gilead Sciences, Inc. (Nasdaq: GILD)  announced  the U.S. Food and Drug Administration (FDA)  appr...
Wednesday, December 3, 2025

FDA Approves Xifyrm (meloxicam) Injection for the Management of Moderate-to-Severe Pain in Adults

›
In continuation of update on Meloxicam Azurity Pharmaceuticals, Inc.  announced the U.S. Food and Drug Administration (FDA)  approval of  Xi...
Tuesday, December 2, 2025

FDA Approves Widaplik (telmisartan, amlodipine and indapamide) for the Treatment of Hypertension

›
George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, announced  the US Foo...
Friday, November 28, 2025

FDA Approves Vizz (aceclidine ophthalmic solution) for the Treatment of Presbyopia

›
Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”),  announced the US Food and Drug Administration (“FDA”) approval of Vizz (acecl...
Thursday, November 27, 2025

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

›
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly,  announced the U.S. Food and Drug Administ...
Thursday, November 20, 2025

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

›
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly,  announced the U.S. Food and Drug Administ...
Wednesday, November 19, 2025

FDA Approves Khindivi (hydrocortisone) Oral Solution for Pediatric Patients with Adrenocortical Insufficiency

›
Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercia...