A letter from 18 Republican senators urges HHS to abandon a Medicare pricing model that aims to balance incentives for developing novel treatments und...
Baxter International issues an urgent medical device correction for its Life2000 Ventilation System due to the potential for patient oxygen desaturati...
FDA approves a Coherus BioSciences BLA for single-dose, prefilled autoinjector presentation of its Udenyca (pegfilgrastim-cbqv), a biosimilar of Amge...
FDA updates its mammography facility regulations to add new patient communication and oversight requirements.
FDA and European Medicines Agency staff describe the benefits seen in their joint Parallel Scientific Advice program.
Lilly says it is terminating the clinical development of solanezumab for preclinical Alzheimers disease after it failed to meet the primary or seconda...
FDA commissioner Robert Califf says in a Stat News interview that FDA is looking for ways to improve and expand its efforts to combat medical misinfor...
FDAs seeks a $372 million (10%) boost and a $150 million increase in user fees in its fiscal year 2024 budget proposal.
