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News about Quality / GMP
Morepen Laboratories Bags Zero-Observation USFDA Inspection for Fourth Time
Morepen Laboratories clears its fourth consecutive USFDA inspection at the Masulkhana facility with zero observations (NIL 483), reinforcing its CDMO strength following a INR 825 crore global manufacturing mandate.
Quality / GMP | 21/04/2026 | By News Bureau | 396
GSK plc Secures China Approval for Blenrep Combination Therapy in Multiple Myelom
National Medical Products Administration approves Blenrep with bortezomib and dexamethasone for relapsed or refractory patients, backed by strong phase III trial outcomes.
Quality / GMP | 21/04/2026 | By News Bureau | 157
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 | 205
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 | 146
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 | 242
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 | 171
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 | 299
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 | 331
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 | 252
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 | 168
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