News about Quality / GMP

BeOne Medicines Wins US FDA Approval for Tevimbra-Based Regimen in HER2-Positive Gastroesophageal Cancer

Tevimbra, Ziihera and chemotherapy combination improves overall and progression-free survival in first-line treatment of unresectable or metastatic HER2-positive gastroesophageal adenocarcinoma.

Quality / GMP | 27/08/2026 | By News Bureau

SK Biopharmaceuticals Secures Global Rights to Biohaven's Opakalim for Epilepsy

SK Biopharmaceuticals will gain exclusive global development and commercialisation rights to opakalim, strengthening its epilepsy portfolio alongside cenobamate and advancing its transition to a multi-product global pharma company.

Quality / GMP | 27/08/2026 | By News Bureau

Insmed's Brinsupri Wins Japan Approval for Non-Cystic Fibrosis Bronchiectasis

Insmed’s Brinsupri (brensocatib) has secured MHLW approval in Japan for non-cystic fibrosis bronchiectasis, expanding access to a new treatment option for patients with the chronic and progressive lung disease.

Quality / GMP | 26/08/2026 | By News Bureau

GSK's Jemperli Receives FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

GSK’s Jemperli has received FDA priority review for previously untreated dMMR/MSI-H locally advanced rectal cancer, following positive phase 2 AZUR-1 results.

Quality / GMP | 26/08/2026 | By News Bureau

Lundbeck's Asedebart Receives EU Orphan Designation for Cushing's Syndrome

Lundbeck’s asedebart receives orphan designation in the European Union for Cushing’s syndrome, supporting its development as a potential targeted therapy for ACTH-driven endocrine disorders.

Quality / GMP | 25/08/2026 | By News Bureau

GSK Receives Japan's First Approval for Bepirovirsen as Functional Cure for Chronic Hepatitis B

Japan’s MHLW approves Hibsago for eligible adults with chronic hepatitis B, following Phase 3 data showing a 19 percent functional cure rate after six months of treatment.

Quality / GMP | 25/08/2026 | By News Bureau

FDA Approves Regeneron's Pasatru to Reduce New Bone Formation in FOP

Regeneron’s Pasatru has received FDA approval for adults with FOP, with Phase 3 OPTIMA data showing up to a 94 percent reduction in new heterotopic ossification lesions compared with placebo.

Quality / GMP | 24/08/2026 | By News Bureau |  553

FDA Grants Accelerated Approval to Ultragenyx's Genglycos for Rare GSDIa

Gene therapy becomes the first treatment designed to directly address the underlying cause of glycogen storage disease type Ia in patients aged eight and older.

Quality / GMP | 21/08/2026 | By News Bureau

Harbour BioMed Secures China IND Approval for HBM7004 in Advanced Solid Tumours

NMPA clearance advances the B7H4xCD3 bispecific antibody toward clinical development, following promising preclinical efficacy and safety results and recent US FDA clearance.

Quality / GMP | 19/08/2026 | By News Bureau

Acurx Pharmaceuticals Secures FDA Conditional Acceptance of Cifbezy Name for Ibezapolstat

Acurx Pharmaceuticals has secured FDA conditional acceptance of Cifbezy as the proposed brand name for ibezapolstat and received USPTO trademark allowance, marking key preparatory milestones ahead of planned international Phase 3 development for C. difficile infection.

Quality / GMP | 18/08/2026 | By News Bureau