Harbour Biomed Ltd. has obtained FDA clearance of its IND application to initiate a first-in-human...

Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...

The FDA has awarded orphan drug designation to Juvena Therapeutics Inc.’s JUV-161, an...

The EMA has awarded orphan drug designation to GC Biopharma Corp.’s intracerebroventricular enzyme replacement therapy (ERT) candidate, GC-1130A, for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A), developed in collaboration with Novel Pharma Inc.

Strand Therapeutics Inc. has received IND clearance from the FDA to initiate a first-in-human phase I trial of STX-001 as a new approach for the treatment of solid tumors.

Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.

Sensorion SA has received approval in Europe for its clinical trial application (CTA) to initiate a...