Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.

Agomab's lung-restricted ALK5 inhibitor showed favourable safety and proof-of-mechanism in IPF patients; a Phase 2 study is set to begin before

Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.

Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.

Immunocore has enrolled 540 patients in its registrational TEBE-AM trial, with topline overall survival data expected as early as end of 2026.

Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to

The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2

Japan's MHLW has approved Elixir Medical's DynamX bioadaptor for coronary artery disease, creating a new device category in the country.

Phase II data for the PD-L1/4-1BB bispecific showed consistent responses regardless of PD-L1 expression, as an NDA advances under NMPA priority

Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.

YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising

Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.