News about Global Pharma

Abbott Secures FDA Clearance and CE Nod for Amplatzer Piccolo Heart Device

Abbott has received US FDA clearance and CE Mark for its Amplatzer Piccolo Delivery System, the first device specifically designed to treat premature infants with Patent Ductus Arteriosus (PDA). The system enables precise placement of the Amplatzer Piccolo Occluder in infants, addressing a condition that affects around 20 percent of premature infants.

Global Pharma | 19/12/2025 | By News Bureau

India Identifies 300 Products to Boost Exports to Russia

The Indian government has identified around 300 products with strong potential to significantly increase exports to Russia, as part of efforts to strengthen bilateral trade ties and move towards a long-term trade target of USD 100 billion by 2030.

Global Pharma | 15/12/2025 | By Darshana |  109

FDA Approves Waskyra Gene Therapy for Wiskott-Aldrich Syndrome

Fondazione Telethon announced that the US FDA has approved Waskyra (etuvetidigene autotemcel), a gene therapy for Wiskott-Aldrich Syndrome (WAS), marking a milestone in both science and clinical care. The approval offers new hope for patients living with this rare immunodeficiency disorder.

Global Pharma | 11/12/2025 | By Akanki

AST and Marchesini Group Partner to Expand Global Market Presence

AST and Marchesini Group have formed a strategic partnership to strengthen their global market presence by combining technology and expertise in aseptic manufacturing. The collaboration aims to accelerate growth and enhance advanced, sterile production capabilities for customers worldwide.

Global Pharma | 11/12/2025 | By Akanki

Japan Grants SAKIGAKE Status to AskBio's Gene Therapy Products, Boosting Global Pharma Manufacturing Momentum

This designation underscores Japan’s commitment to accelerating breakthrough therapies that demonstrate novel mechanisms of action, strong preliminary data, and meaningful potential for addressing severe, underserved conditions.

Global Pharma | 10/12/2025 | By Darshana |  170

Amneal Gets FDA Approval for Epinephrine Vials

The FDA has approved Amneal’s epinephrine injection in both single- and multi-dose vials, strengthening the company’s injectables portfolio with a critical medicine widely used in hospitals for emergency and perioperative care.

Global Pharma | 10/12/2025 | By Akanki

Ouro Medicines Receives US FDA ODD for Gamgertamig (OM336) for Immune Thrombocytopenia

Ouro Medicines has secured a second ODD from the FDA for gamgertamig (OM336), this time for immune thrombocytopenia (ITP), following an earlier designation for autoimmune hemolytic anemia (AIHA). It comes as the company completes dosing in the first cohort of its global basket trial in autoimmune cytopenias.

Global Pharma | 09/12/2025 | By Akanki

China Adds Leqembi to Innovative Drug Insurance List

BioArctic’s partner Eisai said Leqembi has been added to China’s new Commercial Insurance Innovative Drug List, a move by the NHSA that broadens access to the Alzheimer’s therapy for patients in the early stages of the disease.

Global Pharma | 09/12/2025 | By Akanki |  120

HUTCHMED Gains Wider NRDL Coverage and First Commercial Insurance Listing in China

Effective January 1, 2026, HUTCHMED will see expanded NRDL coverage for ELUNATE, ORPATHYS and SULANDA, while TAZVERIK has been added to China’s first National Commercial Health Insurance Innovative Drug List, marking its entry into commercial insurance coverage.

Global Pharma | 08/12/2025 | By Dineshwori

Immix Biopharma Prices USD 100 Million Stock and Pre-Funded Warrant Offering

Immix Biopharma has priced its USD 100 million offering of common stock and pre-funded warrants, with plans to use the proceeds—alongside existing cash reserves—to advance the development of NXC-201 and support working capital and general corporate needs.

Global Pharma | 08/12/2025 | By Dineshwori