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Sovereign Pharma Commissions India's First High-Volume Isolator-Based Ampoule Manufacturing Line
Sovereign Pharma has commissioned its first isolator-based filling line as part of a long-term modernisation plan to upgrade three of its filling lines to advanced isolator systems. The newly commissioned line is fully operational and marks a major milestone in the company’s shift toward next-generation sterile manufacturing.
Platform Technologies Drive USD 211 Billion Surge in Precision Cancer Treatment
The rapid rise of platform technologies has added USD 211 billion in value to the precision oncology landscape, with immunotherapies now accounting for more than 45 percent of global anticancer drug revenues—underscoring strong investor confidence in biologically targeted treatment approaches.
US FDA Approves Uplizna for Adults with Generalised Myasthenia Gravis
The US FDA has approved Uplizna for adults with generalised myasthenia gravis, marking a significant advancement as the first and only CD19-targeted B-cell therapy for both anti-AChR and anti-MuSK antibody–positive patients, offering durable disease control with just twice-yearly dosing.
US FDA Approves Phase III Trial of Cadonilimab Against Nivolumab in Gastric Cancer
The FDA’s clearance enables a global phase III study evaluating Cadonilimab, in combination with chemotherapy, as a first-line option for HER2-negative, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma, directly comparing its efficacy to standard chemotherapy with or without Nivolumab.
Cycle Pharmaceuticals to Acquire Applied Therapeutics
The acquisition positions Cycle Pharmaceuticals to strengthen its rare disease portfolio, adding Applied Therapeutics’ promising CNS-penetrant aldose reductase inhibitor, govorestat, which targets severe unmet needs in central nervous system metabolic disorders.
Alembic Pharma Gets USFDA Nod for Ophthalmic Suspension With CGT Manufacturing Advantage
The product has been granted Competitive Generic Therapy (CGT) designation, making Alembic eligible for 180 days of market exclusivity in the USA once the product is launched. This exclusivity period provides a significant commercial advantage by limiting competition during initial marketing.
D3 Bio Secures USD 108 Million in Series B Financing to Advance Global Clinical Programmes
D3 Bio has raised USD 108 million in Series B financing to advance its global clinical programmes. The funds will support the Phase III pivotal trial of its lead asset, elisrasib (D3S-001), while also accelerating the development of the company’s broader pipeline of targeted and immuno-oncology therapies with first-in-class and best-in-class potential.
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.
Sentynl Appoints myTomorrows as Global Provider to Expand Managed Access Program
Sentynl Therapeutics, a biopharmaceutical company based in the USA and wholly owned by Zydus Lifesciences, has appointed myTomorrows as the global provider for its Managed Access Program (MAP).
MMV Joins iiCON to Boost Infectious Disease Drug Research and Manufacturing Innovation
iiCON, led by the Liverpool School of Tropical Medicine (LSTM), is a global infectious disease R&D programme that unites industry, academic institutions, and clinical bodies to accelerate the development of treatments, diagnostics, and prevention technologies for infectious diseases. Its mission is to save and improve lives.
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