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News about Global Pharma
Mabwell Adalimumab Biosimilar Wins Marketing Approval in Indonesia
Mabwell’s adalimumab biosimilar 9MW0113, co-developed with Junshi Biosciences, has received marketing approval from Indonesia’s BPOM, becoming the first China-developed adalimumab biosimilar to secure such approval, as the company advances global expansion with partnerships in over 10 countries.
Global Pharma | 01/01/2026 | By News Bureau | 164
SN Bioscience's SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer
SNB-101 is a polymer nanoparticle–based anticancer drug that uses SN-38, a highly potent but extremely insoluble active pharmaceutical ingredient.
Global Pharma | 29/12/2025 | By Abha | 342
Sanofi and Novartis have separately entered into agreements with the US government to reduce medicine prices for American patients while reinforcing long-term commitments to US-based manufacturing, research and innovation, marking a coordinated push to balance affordability with sustained pharmaceutical investment.
Global Pharma | 22/12/2025 | By News Bureau | 311
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 | 181
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 | 744
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 | 359
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 | 237
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 | 363
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 | 177
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 | 351
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