News about Quality / GMP

US FDA Grants Fast Track Designation to OncoC4's Cesalatamig

US FDA grants Fast Track Designation to OncoC4’s cesalatamig for patients with NSCLC whose disease has progressed following PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

Quality / GMP | 17/09/2026 | By News Bureau

Japan Approves Enhertu and Datroway for New First-Line Metastatic Breast Cancer Indications

Japan has approved new first-line metastatic breast cancer indications for Daiichi Sankyo’s Enhertu and Datroway, expanding treatment options for patients with HER2-positive and triple-negative breast cancer.

Quality / GMP | 17/09/2026 | By News Bureau |  414

BioViva Secures US Patent for hTERT and Follistatin-344 Combination Therapy

BioViva has received a US patent covering therapeutic methods that combine hTERT and Follistatin-344, expanding its intellectual-property portfolio focused on genetic approaches to aging.

Quality / GMP | 15/09/2026 | By News Bureau

GSK's Shingrix Prefilled Syringe Approves in Japan

GSK’s Shingrix prefilled syringe receives approval in Japan for the prevention of shingles, offering a ready-to-use alternative to the existing two-vial presentation.

Quality / GMP | 11/09/2026 | By News Bureau

Alebund Receives US FDA IND Clearance for IgA Nephropathy Drug Candidate AP308

Alebund Pharmaceuticals has received US FDA IND clearance for AP308, an engineered recombinant IgA protease, paving the way for first-in-human clinical testing in IgA nephropathy.

Quality / GMP | 10/09/2026 | By News Bureau |  108

PannTheraPi Gets French Approval to Advance PTI5803 into Phase 2a Epilepsy Trial

PannTheraPi will evaluate PTI5803 across three dose levels, focusing on safety, tolerability and preliminary efficacy in patients with drug-resistant focal cortical dysplasia-associated epilepsy.

Quality / GMP | 09/09/2026 | By News Bureau |  153

Acepodia Receives FDA Clearance for ACE723 ADC in Advanced Liver Cancer

Acepodia’s ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumour cells in patients with unresectable or metastatic hepatocellular carcinoma.

Quality / GMP | 07/09/2026 | By News Bureau |  113

FibroBiologics Secures US Patent for Fibroblast-Based Wound Healing Therapy

FibroBiologics receives a US patent covering topical fibroblast-based therapies designed to accelerate healing of chronic, diabetic and other difficult-to-heal wounds.

Quality / GMP | 05/09/2026 | By News Bureau

Eisai, Biogen Secure China Approval for Once-Weekly Leqembi Subcutaneous Autoinjector

China approves Leqembi’s once-weekly subcutaneous autoinjector, offering patients with early Alzheimer’s disease a more convenient at-home treatment option.

Quality / GMP | 04/09/2026 | By News Bureau

Hutchmed Grants GSK Worldwide Rights to KRAS-EGFR Cancer Drug Candidate HMPL-A830

Hutchmed and GSK partner to advance HMPL-A830, a first-in-class KRAS-EGFR antibody-targeted therapy conjugate for solid tumours.

Quality / GMP | 04/09/2026 | By News Bureau |  100