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
Advancements in Tenosynovial Giant Cell Tumor Treatment with Surgery and Targeted Therapies

Tenosynovial giant cell tumor, also known as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is primarily treate...

March 05, 2025 | Wednesday | News
Myosin Therapeutics Secures Funding to Advance MT-125 for Glioblastoma, MT-110 for Addiction

 Myosin Therapeutics, Inc., a biotechnology company developing novel therapies for cancer and neurological disorders, has closed its second seed fundi...

March 04, 2025 | Tuesday | News
Telix Pharmaceuticals Announces FDA Acceptance of Biologics License Application for Breakthrough Kidney Cancer Imaging Agent TLX250-CDx

Telix Pharmaceuticals Limited  announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License...

February 26, 2025 | Wednesday | News
Bristol Myers Squibb Announces FDA Acceptance of sBLA for Opdivo® Plus Yervoy® as First-Line Treatment for MSI-H or dMMR Metastatic Colorectal Cancer

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for...

February 25, 2025 | Tuesday | News
Regeneron Reports Promising Results from Phase 1/2 CHORD Trial of Investigational Gene Therapy DB-OTO for Genetic Hearing Loss

Regeneron Pharmaceuticals, Inc. announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 children who have p...

February 25, 2025 | Tuesday | News

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