Biotechnology - BioReview (Page 4)

Pharmaceuticals

Historic FDA Approval: Zycubo Becomes First Treatment for Menkes Disease, Delivering 10-Fold Survival Improvement

Sentynl Therapeutics receives FDA approval for Zycubo, the first and only treatment for Menkes disease, offering a 10-fold improvement in survival for children with this devastating rare genetic disorder.

Biotechnology

Chinese Biotech Abbisko Challenges Established Players in Rare Tumor Market as FDA Accepts Pimicotinib Application

Abbisko Therapeutics' FDA acceptance of pimicotinib NDA marks a significant regulatory milestone in the competitive TGCT market, challenging established players like Deciphera and Daiichi Sankyo.

Biotechnology

Beyond Weight Loss: French Biotech Pioneers First-in-Class GLP-1 Therapy for Joint Disease as Osteoarthritis Market Awaits Its First Disease-Modifying Drug

French biotech 4Moving Biotech achieves FDA IND clearance for 4P004, a first-in-class intra-articular GLP-1 therapy targeting osteoarthritis, potentially becoming the first disease-modifying osteoarthritis drug (DMOAD) to reach patients.

Biotechnology

Oculis Achieves Historic Breakthrough: FDA Grants First-Ever Neuroprotective Therapy Designation for Optic Neuritis

In a landmark achievement that could transform treatment for one of neuro-ophthalmology's most challenging conditions, Oculis Holding AG announced on January 6, 2026, that the FDA has granted Breakthrough Therapy Designation to Privosegtor for the treatment of optic neuritis. This designation marks the first time any investigational therapy

Biotechnology

Revolution Medicines Achieves Historic First: FDA Grants Breakthrough Therapy Designation for KRAS G12D-Targeted Cancer Drug

Revolution Medicines announces FDA Breakthrough Therapy Designation for zoldonrasib, marking the first investigational drug specifically targeting the KRAS G12D mutation to receive this prestigious regulatory recognition.

Biotechnology

Krystal Biotech's Gene Therapy Breakthrough: KB407 Shows Promise in Addressing Cystic Fibrosis at Its Genetic Root

Krystal Biotech announces interim clinical results from its Phase 1 CORAL-1 study of KB407, a potentially mutation-agnostic gene therapy for cystic fibrosis that could transform treatment for all CF patients.

Biotechnology

Jazz Pharmaceuticals' Ziihera Achieves Unprecedented Survival in Gastric Cancer: Over Two Years Median Overall Survival Marks New Treatment Paradigm

Jazz Pharmaceuticals announces unprecedented survival outcomes for Ziihera in HER2-positive gastroesophageal adenocarcinoma, achieving over two years median overall survival—the longest ever reported in a Phase 3 trial for this disease.

Pharmaceuticals

GSK and Ionis Achieve Historic Hepatitis B Breakthrough: First Functional Cure in Phase III Trials

GSK and Ionis announce historic functional cure rates for chronic hepatitis B in Phase III trials with bepirovirsen, potentially transforming treatment for 250 million patients worldwide.

Biotechnology

This Biotech Beat the Market Leader 63%-to-0% in Phase II Trials (NASDAQ: MDWD)

MediWound has a product already on the market, no long-term debt, substantial non-dilutive government funding, and a Phase III asset going after a market dominated by a single 60-year-old drug Chronic wounds are not something most investors think about. But they should. More than 10 million Medicare beneficiaries in the

Biotechnology

Fractyl Health Positions for Breakthrough Year as Post-GLP-1 Weight Maintenance Emerges as Critical Unmet Need

Fractyl Health outlines ambitious 2026 roadmap positioning its Revita system as the first FDA-approved solution for maintaining weight loss after GLP-1 discontinuation, with pivotal clinical data expected this month.

Biotechnology

Ascletis Breaks New Ground in GLP-1 Race with FDA Clearance for Oral Diabetes Treatment

Ascletis Pharma announced FDA IND clearance for ASC30, an oral small molecule GLP-1 receptor agonist for diabetes treatment, marking a significant milestone in the competitive GLP-1 market with a differentiated approach to injectable peptide therapies.

Pharmaceuticals

Canada's Generic Ozempic Revolution Begins Today: Vimy Pharma Leads Charge as Patent Protections Expire

January 4, 2026, marks a watershed moment in the global GLP-1 market as Canada becomes the first country where Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic loses patent protection. Leading the charge into this newly opened market is Toronto-based Vimy Pharma, a startup founded by former Novo