News about Quality / GMP

INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate

INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.

Quality / GMP | 03/07/2026 | By News Bureau |  284

La Chandra Pharmalab Secures US FDA Clearance for Gujarat Hormone API Facility

La Chandra Pharmalab has received a US FDA Establishment Inspection Report (EIR) for its Banaskantha hormone API manufacturing facility, reinforcing its position in regulated markets and advancing India's capabilities in hormone API manufacturing.

Quality / GMP | 03/07/2026 | By News Bureau |  162

BeOne Medicines Reports Positive Phase 3 Results for Brukinsa in First-Line Mantle Cell Lymphoma

BeOne Medicines has reported positive Phase 3 results from the MANGROVE trial, showing that Brukinsa combined with rituximab significantly improves progression-free survival in previously untreated mantle cell lymphoma.

Quality / GMP | 02/07/2026 | By News Bureau |  123

Akums Launches DCGI-Approved Triple-Action Therapy for Diabetic Neuropathic Pain

Akums Drugs & Pharmaceuticals has introduced a DCGI-approved triple-action capsule that combines pregabalin, methylcobalamin and delayed-release duloxetine to offer comprehensive management of diabetic peripheral neuropathic pain while supporting nerve regeneration.

Quality / GMP | 01/07/2026 | By News Bureau |  189

Artivion Secures US FDA Approval for AMDS Hybrid Prosthesis to Treat Acute Aortic Dissections

Artivion has received US FDA approval for its AMDS Hybrid Prosthesis, enabling broader adoption of the aortic arch remodelling device that has demonstrated significant reductions in mortality and major complications for patients with acute DeBakey Type I aortic dissections.

Quality / GMP | 01/07/2026 | By News Bureau |  150

Roche's Enspryng Receives FDA Priority Review for Thyroid Eye Disease

Roche's Enspryng has received FDA Priority Review for thyroid eye disease after Phase 3 studies demonstrated clinically meaningful improvements in eye bulging, disease activity and double vision, with a regulatory decision expected by October 2026.

Quality / GMP | 01/07/2026 | By News Bureau |  132

Nuvation Bio's Taletrectinib Advances UK Regulatory Review for ROS1-Positive Lung Cancer

The UK's MHRA has validated the marketing application for Nuvation Bio's taletrectinib, bringing the next-generation ROS1 inhibitor one step closer to approval for patients with advanced ROS1-positive non-small cell lung cancer in the UK.

Quality / GMP | 01/07/2026 | By News Bureau |  119

US FDA approves Viridian's Lumvoa for treatment of thyroid eye disease

Viridian Therapeutics secures US FDA approval for Lumvoa, the first IGF-1R antagonist approved to treat both active and chronic thyroid eye disease, with commercial launch set to begin immediately.

Quality / GMP | 30/06/2026 | By News Bureau |  101

Jubilant Generics Receives USFDA Tentative Approval for Pantoprazole Sodium Oral Suspension

FDA’s tentative approval strengthens Jubilant Generics' US product pipeline and positions the company to launch Pantoprazole Sodium Delayed Release Oral Suspension following patent expiry later this year.

Quality / GMP | 30/06/2026 | By News Bureau |  118

EMA Recommends Approval of Datroway for First-Line Treatment of Triple-Negative Breast Cancer

AstraZeneca and Daiichi Sankyo have received a positive recommendation from the European Medicines Agency's CHMP for Datroway as a first-line treatment for unresectable or metastatic triple-negative breast cancer in patients who are not eligible for immunotherapy, supported by Phase 3 trial results demonstrating improved survival and disease control.

Quality / GMP | 29/06/2026 | By News Bureau |  166