News about Quality / GMP

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

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

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

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

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

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

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

Armata Pharmaceuticals Receives FDA Fast Track Designation for AP-SA02 Bacteriophage Therapy

The FDA has granted Fast Track designation to Armata’s AP-SA02 therapy for the adjunct treatment of complicated Staphylococcus aureus bacteremia caused by MSSA and MRSA infections.

Quality / GMP | 07/05/2026 | By News Bureau

Atossa Therapeutics Secures FDA Rare Pediatric Disease Tag for (Z)-Endoxifen in McCune-Albright Syndrome

Atossa Therapeutics receives US Food and Drug Administration (FDA) Rare Pediatric Disease designation for (Z)-Endoxifen in McCune-Albright syndrome, qualifying for Priority Review Voucher award upon approval.

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

Australia Approves First-in-Class Niktimvo for Chronic GVHD Treatment

Niktimvo approval marks a major breakthrough in treating chronic GVHD, introducing a first-in-class targeted therapy for patients with limited treatment options and high unmet medical need.

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