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

ImmunityBio’s ANKTIVA wins EMA nod for early EU approval in hard-to-treat bladder cancer

Accenture invests in Ryght AI to revolutionize clinical trials

Ryght AI tackles these hurdles with its AI Site Twin platform

Shelter Pharma launches D3 cure capsules

This launch is part of the company's strategy to expand its nutraceutical portfolio

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

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 flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

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

Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies

Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD