fda-and-biotech News
IMDX surges 3.5% on FDA submission for transplant test
First kitted dd-cfDNA assay submission marks milestone for kidney transplant rejection testing
Gain Therapeutics beats loss estimates on Parkinson's drug progress
Clinical-stage biotech narrows Q4 loss to $0.11 per share, doubles cash reserves
Denali surges on FDA approval of first Hunter syndrome drug in 20 years
AVLAYAH marks breakthrough in crossing blood-brain barrier, opening new path for neurological treatments
Beam Therapeutics surges on gene therapy data supporting accelerated FDA pathway
BEAM-302 trial demonstrates sustained protective protein levels, positioning company for accelerated approval in alpha-1 antitrypsin deficiency
ImmunityBio Plunges 23% After FDA Warning Over Anktiva Claims
Regulator says promotional materials overstated cancer therapy's effectiveness in third compliance action
Achieve Life Sciences misses EPS, maintains June FDA catalyst
U.S. manufacturing partnership with Adare Pharma Solutions secures supply chain as cytisinicline decision approaches
Pfizer Lyme vaccine shows 74% efficacy but misses primary endpoint
Drugmaker plans FDA approval push despite statistical shortfall in Phase 3 VALOR trial as $1B market opportunity looms
Rhythm Pharmaceuticals surges after FDA approval of obesity drug
IMCIVREE becomes first-ever therapy for acquired hypothalamic obesity, expanding addressable market