News about Quality / GMP

MHRA Approves Use of UK-Donor Plasma for Five Additional Life-Saving Medicines

The UK's Medicines and Healthcare products Regulatory Agency has approved the use of UK-donor plasma for producing five additional plasma-derived medicines after determining that the risk of variant Creutzfeldt-Jakob disease (vCJD) transmission is negligible. The decision is expected to improve the resilience of the UK's plasma medicine supply chain.

Quality / GMP | 10/07/2026 | By News Bureau

Roche Receives CE Mark for Automated Blood Test to Detect Latent Tuberculosis Infection

Roche's Elecsys IGRA TB test enables tuberculosis infection screening with results in under 24 hours, offering faster laboratory workflows and supporting efforts to improve TB diagnosis and control.

Quality / GMP | 10/07/2026 | By News Bureau

US FDA Issues Complete Response Letter for Ascelia Pharma's Orviglance NDA

Ascelia Pharma has received a Complete Response Letter from the US FDA for its New Drug Application for Orviglance, prompting the company to seek further regulatory discussions while reaffirming its commitment to advancing the rare oncology therapy.

Quality / GMP | 06/07/2026 | By News Bureau |  182

UK MHRA Approves Wegovy for Treatment of MASH in Adults with Liver Fibrosis

The UK's Medicines and Healthcare products Regulatory Agency has conditionally approved Novo Nordisk's Wegovy (semaglutide) for treating metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis, subject to ongoing confirmatory clinical data.

Quality / GMP | 06/07/2026 | By News Bureau

Eisai seeks UK Approval for Insomnia Therapy Lemborexant

Eisai has submitted lemborexant for regulatory review in the UK, aiming to expand treatment options for adults suffering from chronic insomnia and improve patients' daytime functioning.

Quality / GMP | 04/07/2026 | By News Bureau

Vyome Secures China Patent for Besifloxacin Topical Gel in Inflammatory Acne Treatment

Vyome Holdings has secured a Chinese patent for its proprietary besifloxacin topical gel programme, strengthening intellectual property protection for inflammatory acne treatment and expanding future commercial opportunities in one of the world's largest dermatology markets.

Quality / GMP | 04/07/2026 | By News Bureau

China Approves Hengrui Pharma's Water-Free Cyclosporine Eye Drop for Dry Eye Disease

China's drug regulator has approved Hengrui Pharma's Heng Yi, the country's first water-free 0.1 percent cyclosporine ophthalmic solution, expanding treatment options for patients with dry eye disease through Novaliq's EyeSol technology.

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

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 |  167

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

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