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Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy
R&D | January 08, 2026

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production


Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter
Medical Device | January 08, 2026

Stereotaxis scores FDA nod for groundbreaking MAGiC robotic heart catheter

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures


Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy
News | January 08, 2026

Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy

REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS


Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
Clinical Trials | January 08, 2026

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety


Briefs: Medicamen Biotech and Gland Pharma
Drug Approval | January 08, 2026

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


Dr. Reddy's launches novel recombinant Hepatitis E vaccine ‘Hevaxin’ in India
News | January 07, 2026

Dr. Reddy's launches novel recombinant Hepatitis E vaccine ‘Hevaxin’ in India

It is currently the only vaccine authorized by the Drug Controller General of India (DCGI) for active immunization against HEV in adults aged 18 to 65


Subcutaneous Saphnelo cuts lupus disease activity in phase III trial
Biopharma | January 07, 2026

Subcutaneous Saphnelo cuts lupus disease activity in phase III trial

SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage


Medera doses final patient in high-dose HFpEF gene therapy trial
Biopharma | January 07, 2026

Medera doses final patient in high-dose HFpEF gene therapy trial

Heart failure affects an estimated 64.3 million people worldwide


WuXi Biologics secures ISO 20400 certification
Sustainability | January 07, 2026

WuXi Biologics secures ISO 20400 certification

WuXi Biologics has integrated sustainability principles throughout its supplier lifecycle management