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Results For "PLI"

3520 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


FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA
Drug Approval | January 05, 2026

FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA

The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement


Caplin Point Labs acquires 10 ANDAs, targets $473M US market
News | January 03, 2026

Caplin Point Labs acquires 10 ANDAs, targets $473M US market

The portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025


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


Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial
Clinical Trials | December 22, 2025

Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial

The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile


SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery
R&D | December 20, 2025

SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery

SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements


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