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3708 News Found

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


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


Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader
Opinion | January 07, 2026

Reimagining India’s Pharmaceutical Sector: From Global Supplier to Innovation Leader

India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry


Savara resubmits FDA application for potential treatment in rare lung disease patients
Biopharma | January 01, 2026

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer


Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant


Novo Nordisk files FDA application for once-weekly obesity drug CagriSema
News | December 19, 2025

Novo Nordisk files FDA application for once-weekly obesity drug CagriSema

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection


Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain
News | December 12, 2025

Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets


Teva files FDA application for once-monthly schizophrenia injection
Drug Approval | December 11, 2025

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time


Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids
Biopharma | December 10, 2025

Croda strikes strategic deal with Amino to boost global supply of high-purity amino acids

The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities


Otsuka files FDA application for first-in-class ADHD drug
Clinical Trials | November 27, 2025

Otsuka files FDA application for first-in-class ADHD drug

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor