Hansa Biopharma submits imlifidase Biologics License Application to FDA

T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM

Alvotech and Teva secure US launch date for Eylea biosimilar AVT06

Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency

Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark

Amphix Bio announces initial closing of USD12.5m seed financing round

BiBBInstruments reports additional US orders during targeted EndoDrill GI launch

Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema

Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation

Nicox completes key data package for NCX 470 NDA submissions

Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II

Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon

Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin

Amferia raises EUR3.5m to advance antimicrobial wound-care platform

Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion