News about Quality / GMP

Chugai Secures World's First Tumour-Agnostic Approval for ALK Inhibitor Alecensa in Japan

Chugai Pharmaceutical has received regulatory approval in Japan for the expanded use of Alecensa (alectinib) in advanced or recurrent ALK fusion-positive solid tumours, marking the world’s first tumour-agnostic approval for an ALK inhibitor.

Quality / GMP | 19/05/2026 | By News Bureau |  251

Lundbeck Secures Orphan Drug Designation in Japan for Asedebart Targeting Rare Endocrine Disorders

Lundbeck has received orphan drug designation in Japan for asedebart, an investigational ACTH-targeting therapy being developed for congenital adrenal hyperplasia and Cushing’s disease.

Quality / GMP | 18/05/2026 | By News Bureau |  167

FDA Clears IND Application for Chengdu Origen's Gene Therapy Targeting Hypertrophic Cardiomyopathy

Chengdu Origen Biotechnology and Vanotech have received US FDA clearance to begin clinical evaluation of KHN921, a potential first-in-class gene therapy designed to address the genetic root cause of hypertrophic cardiomyopathy linked to MYBPC3 mutations.

Quality / GMP | 16/05/2026 | By News Bureau |  223

FDA Grants Accelerated Approval to BeOne Medicines' Beqalzi for Relapsed Mantle Cell Lymphoma

BeOne Medicines has secured accelerated US FDA approval for Beqalzi (sonrotoclax) to treat relapsed or refractory mantle cell lymphoma, marking an advancement in targeted therapies for patients with limited treatment options.

Quality / GMP | 16/05/2026 | By News Bureau |  153

Indoco Remedies Clears Malta Medicines Authority Audit

Indoco Remedies receives EU GMP certification from the Malta Medicines Authority, validating compliance with European Good Manufacturing Practice (GMP) standards.

Quality / GMP | 15/05/2026 | By News Bureau |  120

Pfizer Secures EC Approval to Expand Hympavzi Use for Haemophilia Patients with Inhibitors

Pfizer has secured European Commission approval to expand the use of Hympavzi for haemophilia A and B patients with inhibitors, offering a once-weekly subcutaneous treatment option designed to reduce bleeding episodes and improve disease management.

Quality / GMP | 14/05/2026 | By News Bureau |  116

Roche Receives CE Mark for Blood-Based Alzheimer's Diagnostic Test

Roche receives CE Mark approval for Elecsys pTau217, a blood-based Alzheimer’s diagnostic test developed with Eli Lilly, aimed at enabling earlier and less invasive detection of amyloid pathology in patients with cognitive decline.

Quality / GMP | 13/05/2026 | By News Bureau |  116

Rznomics Secures US FDA RMAT Designation for Liver Cancer Gene Therapy Candidate RZ-001

The FDA has granted Regenerative Medicine Advanced Therapy designation to RZ-001, an RNA-based gene therapeutic for hepatocellular carcinoma, accelerating its clinical development and regulatory review pathway.

Quality / GMP | 11/05/2026 | By News Bureau |  129

Harbour BioMed Secures FDA IND Clearance for HBM7004 in Advanced Solid Tumors

Harbour BioMed receives US Food and Drug Administration (FDA) IND clearance for HBM7004, a novel B7H4xCD3 bispecific antibody developed on its HBICE platform for advanced solid tumors.

Quality / GMP | 11/05/2026 | By News Bureau |  162

Chance Pharma Secures NMPA Acceptance for CXG87 Respiratory Drug NDA

Chance Pharma secures National Medical Products Administration acceptance of NDA for CXG87, marking its first filing and a key step toward commercialisation of a novel respiratory therapy.

Quality / GMP | 08/05/2026 | By News Bureau |  129