Johnson & Johnson’s TREMFYA® Approved by FDA as First Dual-Acting IL-23 Inhibitor for Crohn’s Disease

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab), the first and only IL-23...

March 24, 2025 | Monday | News
Novartis Wins FDA Approval for Fabhalta®, First Oral Therapy for C3G

Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with ...

March 24, 2025 | Monday | News
FDA Clears Altesa BioSciences' IND for Vapendavir to Treat Rhinovirus Infections in COPD Patients

Altesa BioSciences, Inc., a clinical-stage pharmaceutical company dedicated to developing new treatments for viral infections in vulnerable populations, an...

March 21, 2025 | Friday | News
Moon Surgical Secures FDA Clearance for ScoPilot, First AI-Powered Intraoperative Tool

Moon Surgical, a French-American pioneer in surgical innovation, announced the United States Food and Drug Administration (FDA) clearance for ScoPilot. Ena...

March 20, 2025 | Thursday | News
Amgen’s UPLIZNA® Shows Lasting Efficacy in Phase 3 MINT Trial

Amgen announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults ...

March 18, 2025 | Tuesday | News
Sanofi Accelerates Flu Vaccine Production for 2025-26 Season, Aligning with FDA-Selected Strains

Sanofi announced the immediate adoption of influenza strains selected by the US Food and Drug Administration (FDA) to advance the manufacturing and ...

March 17, 2025 | Monday | News
Dr. Reddy’s Recalls Levetiracetam Injection in the U.S. Due to Mislabeled Infusion Bags

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “D...

March 14, 2025 | Friday | News
Celltrion Launches STEQEYMA® (Ustekinumab-stba) in the U.S. Following FDA Approval, Offering a Cost-Effective Biosimilar Alternative to STELARA®

Celltrion announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), following approval by the U....

March 13, 2025 | Thursday | News
Ionis and Ono Pharmaceutical Partner on Sapablursen for Polycythemia Vera with Exclusive Global Rights Agreement

 Ionis Pharmaceuticals, Inc. and Ono Pharmaceutical Co., Ltd (Ono), announced that the two companies have entered into a license agreement in whi...

March 12, 2025 | Wednesday | News
Celltrion Wins FDA Approval for OMLYCLO®, First Interchangeable Biosimilar to XOLAIR®

Celltrion announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimila...

March 10, 2025 | Monday | News
Acadia Reports Positive DAFFODIL™ Study Results for DAYBUE® in Rett Syndrome

Acadia Pharmaceuticals Inc.  announced that the journal Med published results from the open-label study, DAFFODIL™, evaluating the saf...

March 06, 2025 | Thursday | News
BeiGene Wins FDA Approval for TEVIMBRA® in First-Line Esophageal Cancer Treatment

BeiGene, Ltd.  a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the U.S. Food and Drug Administr...

March 06, 2025 | Thursday | News
Neurocrine Biosciences Begins Phase 1 Trial for NBI-1140675 in Neurological Disorders

Neurocrine Biosciences, Inc. announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynami...

March 06, 2025 | Thursday | News
FDA Accepts Roche’s sBLA for Gazyva®/Gazyvaro® (Obinutuzumab) as a Treatment for Lupus Nephritis

Roche announced  that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for...

March 06, 2025 | Thursday | News

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