FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

Biocon launches its Glucagon-like Peptide-1, Liraglutide, in the Netherlands

Godavari Biorefineries ED Sangeeta Srivastava named BRSI Honorary Fellow

Dr Srivastava was selected by an expert jury in recognition of her sustained contributions to renewable chemicals, industrial biotechnology and bioprocess innovation

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia

Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome

The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste

Sobi to acquire Arthrosi Therapeutics in $950 million deal, bolstering gout pipeline

The drug is currently being evaluated in two fully recruited global Phase 3 studies for progressive and tophaceous gout, with results expected in 2026.

Anova launches AI-powered patient matching platform to speed clinical trial enrollment

Clinical trial enrollment has long been a bottleneck in drug development

Caplin Point Laboratories’ injectables facility completes INVIMA audit successfully

This is also an important milestone in our product strategy for our expansion into the larger Latin American market

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility