Kedrion Secures EMA Orphan Drug Designation for Investigational Aceruloplasminemia Therapy

  Kedrion announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its investigational treatment for Congenita...

November 28, 2025 | Friday | News
BeOne Medicines’ Sonrotoclax Granted FDA Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has a...

November 27, 2025 | Thursday | News
Galux Demonstrates Precision AI Platform That Delivers Drug-Grade Antibodies in Weeks

-Galux, a South Korean biotech pioneering AI-driven protein therapeutics design, announced new experimental findings demonstrating that its AI protein de...

November 27, 2025 | Thursday | News
Sarepta Receives FDA Approval to Initiate Cohort 8 Evaluating Sirolimus With ELEVIDYS in Non-Ambulant Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to be...

November 26, 2025 | Wednesday | News
MDA Applauds FDA Approval of Itvisma, the First Gene Replacement Therapy for a Broad SMA Population

The Muscular Dystrophy Association (MDA)  called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve), ...

November 26, 2025 | Wednesday | News
EMD Serono Advances First Potential Oral gMG Therapy with FDA Fast Track Designation

  Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, g...

November 25, 2025 | Tuesday | News
MindImmune Closes $10.2M Series A Extension to Advance First-in-Class Alzheimer’s Therapeutic

MindImmune Therapeutics, a private company developing new treatments targeting the inflammatory drivers of neurodegenerative disease, announced two major...

November 25, 2025 | Tuesday | News
AGC Biologics Partners with AAVantgarde to Advance Dual-Vector AAV Gene Therapies for Inherited Blindness

Partnership accelerates AGC Biologics' leadership in the AAV market, applying its BravoAAV™ platform to complex gene therapies for inherited blin...

November 24, 2025 | Monday | News
Actimed and Mankind Pharma Sign Exclusive Licensing Deal for Cachexia Treatments in India and South Asia

Covers exclusive rights to S-pindolol, the novel therapy in development for the treatment of cachexia, in India and South Asia Represents a major step...

November 24, 2025 | Monday | News
Psyence BioMed Secures Sustainable, GMP-Compliant Iboga Supply Through PsyLabs to Advance Ibogaine Clinical Development

Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived p...

November 21, 2025 | Friday | News
NeuroThera Labs and Clearmind File Israeli Patent for Novel MEAI–PEA Combination Therapy Targeting Depression

SciSparc Ltd. announced that NeuroThera Labs Inc. , a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous sy...

November 21, 2025 | Friday | News
Profluent Raises $106M to Accelerate Frontier AI for Programmable Biology

Profluent, a leader in frontier AI for protein design,  announced a $106 million financing co-led by Altimeter Capital and Bezos Expeditions, with p...

November 20, 2025 | Thursday | News
Thermo Fisher Opens Flagship United States Center in Philadelphia to Accelerate Cell & Gene Therapy Development

  New state-of-the-art facility in Philadelphia provides integrated lab and collaboration space along with tailored guidance to help move advanced th...

November 19, 2025 | Wednesday | News
Harrow Enters Procedural Sedation Market With Acquisition of Melt Pharmaceuticals

Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America,  announced that it has completed the acquisit...

November 19, 2025 | Wednesday | News

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