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OS Therapies files patent for immune-response biomarker linked to cancer immunotherapy
New data from the Phase IIb trial of OST-HER2 shows distinct immune signatures tied to improved survival outcomes, supporting accelerated approval discussions with global regulators.
Quality / GMP | 20/04/2026 | By News Bureau
Merck receives European Commission approval for ENFLONSIA (clesrovimab), a novel RSV preventive therapy for infants, designed to protect against lower respiratory tract disease during their first RSV season.
Quality / GMP | 20/04/2026 | By News Bureau | 109
Alembic Pharmaceuticals Gets US FDA Nod for Methotrexate Injection
Alembic Pharmaceuticals secures USFDA approval for Methotrexate Injection USP in multi-dose and single-dose vials, a key folate analog metabolic inhibitor used in the treatment of various neoplastic diseases.
Quality / GMP | 17/04/2026 | By News Bureau
The US Food and Drug Administration reviews concerns over Ocrevus, as safety and efficacy questions emerge for its use in primary progressive multiple sclerosis patients.
Quality / GMP | 16/04/2026 | By News Bureau | 191
The partnership among Orbicular Pharmaceutical Technologies, Gland Pharma and Apotex, achieves first ANDA approval with Competitive Generic Therapy designation, gaining six-month exclusivity for complex multivitamin injectable in the United States.
Quality / GMP | 16/04/2026 | By News Bureau | 156
Travere Secures Full US FDA Approval for FILSPARI
Travere Therapeutics secures full US FDA approval for FILSPARI (sparsentan) to treat FSGS, expanding access to over 100,000 patients with a therapy aligned with KDIGO guidelines.
Quality / GMP | 15/04/2026 | By News Bureau | 112
European Commission Approves Dupixent for Young Children with Chronic Spontaneous Urticaria
The European Commission has expanded approval of Dupixent to children aged 2–11 with chronic spontaneous urticaria, offering a targeted treatment for those unresponsive to standard antihistamines.
Quality / GMP | 15/04/2026 | By News Bureau | 100
Roche Secures CE Mark for Blood-Based Test to Monitor Multiple Sclerosis
Roche’s Elecsys NfL test receives CE approval, offering a simple blood-based method to detect neuroinflammation in multiple sclerosis, improving monitoring access and supporting more timely, personalised disease management.
Quality / GMP | 14/04/2026 | By News Bureau
MHRA Approves Olezarsen (Tryngolza) for Familial Chylomicronemia Syndrome
MHRA approves olezarsen (tryngolza) for adults with Familial Chylomicronemia Syndrome with subcutaneous injection administration.
Quality / GMP | 13/04/2026 | By News Bureau
Lynk Pharmaceuticals Secures NMPA NDA Acceptance for Zemprocitinib
Lynk Pharmaceuticals announces NMPA acceptance of Zemprocitinib NDA, backed by positive results from a phase-III randomised, double-blind, placebo-controlled clinical trial in China.
Quality / GMP | 11/04/2026 | By News Bureau
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