News about Quality / GMP

Can-Fite BioPharma Secures Australian Patent for Namodenoson in Advanced Metastatic Cancer

Can-Fite BioPharma has secured an Australian patent covering the use of Namodenoson for advanced metastatic cancer, strengthening intellectual property protection as the drug advances through late-stage clinical development for liver and pancreatic cancers.

Quality / GMP | 15/07/2026 | By News Bureau

TolerogenixX Secures EU Orphan Drug Designation for MIC-Lx in Living-Donor Kidney Transplantation

European Commission grants orphan status to Tolerogenix’s personalized cell therapy following EMA recommendation, strengthening its regulatory pathway alongside recent PRIME designation.

Quality / GMP | 14/07/2026 | By News Bureau

China Grants Priority Review to Leads Biolabs' Opamtistomig for Advanced Neuroendocrine Carcinoma

NMPA accepts biologics license application under expedited review pathway for investigational PD-L1/4-1BB bispecific antibody targeting advanced extrapulmonary neuroendocrine carcinoma after multiple prior therapies.

Quality / GMP | 13/07/2026 | By News Bureau

OKYO Pharma Receives FDA Support to Advance Urcosimod into Global Phase 3 Trial

Positive feedback from the US FDA has reinforced OKYO Pharma's clinical development strategy for urcosimod, with the company preparing to launch a global Phase 3 trial for neuropathic corneal pain, a debilitating eye disorder that currently lacks FDA-approved therapies.

Quality / GMP | 13/07/2026 | By News Bureau

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 |  119

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 |  228

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