FDA Unveils Plausible Mechanism Pathway to Accelerate Bespoke Gene Editing Therapies
FDA officials Vinay Prasad and Marty Makary have unveiled a new “plausible mechanism pathway” designed to accelerate bespoke gene-editing therapies.
FDA Updates
FDA Unveils Second Wave of National Priority Voucher Winners, Featuring Obesity Leaders Lilly and Novo Nordisk
Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.) FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies The U.S. Food and Drug Administration (FDA) has announced a significant … Read more
Sanofi Secures Breakthrough FDA Review for Tzield
Sanofi’s Tzield gains FDA review for stage 3 T1D.
FDA’s BsUFA III Framework: What It Means for Biosimilar Sponsors
FDA defines biosimilar PAS & CBE under BsUFA III
Stryker’s Incompass Total Ankle Wins FDA Clearance
Stryker FDA-cleared InCompass Ankle; protein degrader partnerships drive innovation.
FDA Import Ban Disrupts Olympus’ US Medical Supply
FDA import ban issued on Olympus medical devices from Japan for quality violations.
Randox Gains FDA De Novo Clearance for Hemophilia CDx
Randox Laboratories has secured FDA de novo clearance for its ConcizuTrace ELISA companion diagnostic, designed to quantify plasma concentrations of Novo Nordisk’s recently approved hemophilia treatment Alhemo (concizumab-mtci). The regulatory milestone comes just weeks after Alhemo received FDA approval in December 2024 as a once-daily prophylactic injection for adults and pediatric patients 12 years and … Read more
LifeScience Weekly Digest: Key Industry Updates (13th – 17th January)
JP Morgan Week featured notable developments in drugs, devices, diagnostics, and digital health. Johnson & Johnson paid $14.6 billion for Intra-Cellular Therapies, bolstering its neuroscience portfolio with CAPLYTA® and a strong mental health pipeline. Eli Lilly invested $2.5 billion in Scorpion Therapeutics’ PI3Kα inhibitor for hormone-positive breast cancer, while Bausch + Lomb expanded ophthalmology with … Read more