The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to United States-based Usona Institute's psilocybin intended for the treatment of major depressive disorder (MDD), it was reported yesterday.
Breakthrough Therapy Designation establishes the FDA's organisational commitment to promoting an efficient development program for psilocybin in MDD.
The new status follows the recent introduction of Usona's Phase two clinical trial, PSIL201, which included around 80 participants at seven study sites around the US. Two of the seven study sites are presently hiring, with the others expected to be active by the first quarter of 2020.
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