HHS acting general counsel Sean Keveney is appointed FDAs new chief counsel.
FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystrophy that is amenable t...
FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.
FDA issues Regeneron a second complete response letter on its BLA for odronextamab and its use in relapsed/refractory follicular lymphoma after citing...
Allogene Therapeutics modifies its ALPHA3 clinical trial for large B-cell lymphoma following the death of a patient attributed to its investigational ...
FDA approves LENZ Therapeutics Vizz (aceclidine ophthalmic solution) 1.44% for treating presbyopia, a common age-related condition that causes blurry ...
Illumina agrees to pay $9.8 million to settle allegations that it violated the False Claims Act by selling genomic sequencing systems with known cyber...
Draeger recalls (Class 1) its SafeStar 90 Plus bidirectional breathing system filter after receiving reports of slow increase of CO2-curve when a gas ...
