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News about Quality / GMP
Rusan Pharma Wins Japan PMDA GMP Nod for Two Key Plants
Rusan Pharma secures Japan PMDA GMP approval for its Ankleshwar and Dehradun facilities, covering both API and finished manufacturing dosage units.
Quality / GMP | 21/04/2026 | By News Bureau | 163
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 | 129
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 | 192
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 | 140
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 | 269
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 | 277
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 | 181
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 | 140
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 | 147
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 | 129
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