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Results For "PLI"

4286 News Found

Caplin Steriles gets USFDA approval for Sodium Phosphate injection
Drug Approval | February 25, 2026

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake


AIM ImmunoTech advances Phase 2 pancreatic cancer trial with Ampligen and Imfinzi
News | February 24, 2026

AIM ImmunoTech advances Phase 2 pancreatic cancer trial with Ampligen and Imfinzi

The study is a collaboration between AIM, AstraZeneca, and Erasmus Medical Center in the Netherlands


FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
Drug Approval | February 21, 2026

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study


Amgen scores EU nod for UPLIZNA in rare autoimmune disease
News | February 16, 2026

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses


FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue
Drug Approval | February 14, 2026

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”


GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth
News | February 10, 2026

GSK India crosses Rs. 1,000 crore mark, key portfolios drive 8.1% topline growth

Launched in August 2025, GSK India’s Oncology business is rapidly gaining momentum


Venus Remedies bags second PLI disbursement for FY25, nears full-year incentive
News | January 29, 2026

Venus Remedies bags second PLI disbursement for FY25, nears full-year incentive

The successive PLI disbursements validate our disciplined execution and sustained commitment to strengthening India’s domestic pharmaceutical manufacturing capabilities


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