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
Chime Biologics Advances MG-K10, Novel IL-4Rα Antibody, into U.S. Phase III Trials with Mabgeek

Chime Biologics, a leading global CDMO that enables its partners success in biologics, announced its continued collaboration with Mabgeek in adva...

February 24, 2025 | Monday | 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
Incyte and Genesis Therapeutics Forge Strategic Collaboration to Accelerate Small Molecule Drug Discovery Using AI

Incyte  and Genesis Therapeutics, Inc. announced  that the companies have entered into a strategic collaboration focused on the researc...

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
GSK Announces China’s Acceptance of New Drug Application for Nucala (Mepolizumab) as COPD Treatment

GSK plc announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala ...

February 21, 2025 | Friday | News
Genprex Advances Diabetes Program with Strategic Collaboration to Explore Non-Viral Gene Therapy Delivery System

Genprex, Inc., a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced the adv...

February 20, 2025 | Thursday | 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
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
Gilead Sciences Announces FDA Acceptance of NDA for Lenacapavir as Twice-Yearly HIV Prevention Treatment

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapa...

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
Sanofi and Regeneron’s Dupixent Gains FDA Priority Review for Bullous Pemphigoid Treatment

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) t...

February 19, 2025 | Wednesday | News

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