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
EMA Approves New 2 mL Pre-Filled Pen Option for TAKHZYRO® to Treat Hereditary Angioedema in Adolescents and Adults

Takeda announced that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in...

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
FDA Approves Ctexli (Chenodiol) as the First Treatment for Cerebrotendinous Xanthomatosis (CTX) in Adults

The U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is ...

February 24, 2025 | Monday | News
Innovent Biologics’ Ipilimumab Injection Receives NDA Acceptance and Priority Review for MSI-H/dMMR Colon Cancer in China

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment o...

February 24, 2025 | Monday | News
Ionis Pharmaceuticals to Present New Data on Donidalorsen for Hereditary Angioedema at AAAAI/WAO Joint Congress

Ionis Pharmaceuticals, Inc.  announced that it will present additional data from the pivotal Phase 3 OASIS and OASISplus studies, as well as three yea...

February 21, 2025 | Friday | News
European Commission Grants Conditional Marketing Authorization for Gilead’s Seladelpar in Primary Biliary Cholangitis

Gilead Sciences, Inc. announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of prima...

February 21, 2025 | Friday | News
Bristol Myers Squibb Announces Positive Final Overall Survival Data for Opdivo® in Resectable NSCLC

Bristol Myers Squibb announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo (ni...

February 21, 2025 | Friday | News
Phanes Therapeutics Doses First Patient in Clinical Trial of Peluntamig (PT217) for Advanced Cancers

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced that the f...

February 20, 2025 | Thursday | News
Spinal Cord Injury (SCI) Cases Expected to Rise by 2034, Highlighting the Need for Improved Treatments and Support

Spinal cord injury (SCI) is a sudden disruption of the spinal cord's neural tissue within the spinal canal, caused by trauma, disease, or degeneration. Thi...

February 20, 2025 | Thursday | News
Merilog Receives FDA Approval as the First Rapid-Acting Insulin Biosimilar

The U.S. Food and Drug Administration (FDA) approved Merilog (insulin aspart szij) as a Novolog biosimilar to (insulin aspart) to improve glycemi...

February 20, 2025 | Thursday | News
Ultragenyx Announces FDA Acceptance of BLA for UX111 Gene Therapy to Treat Sanfilippo Syndrome Type A

Ultragenyx Pharmaceutical Inc. announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted for review the Biologics License Applicatio...

February 19, 2025 | Wednesday | News
Grifols Completes Recruitment for Phase 1/2 Study of Subcutaneous Alpha1-Proteinase Inhibitor for AAT Deficiency

Grifols , a global healthcare company and leading manufacturer of plasma-derived medicines,  announced it has finished recruiting the second cohort of...

February 19, 2025 | Wednesday | News
Biogen and Stoke Therapeutics Collaborate on Zorevunersen for Dravet Syndrome Treatment

Biogen Inc.  and Stoke Therapeutics, Inc. announced a collaboration for the development and commercialization of zorevunersen, a potential f...

February 19, 2025 | Wednesday | News

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