A bipartisan group of U.S. Senators and House members call on FDA to step up its regulatory activities to improve rare disease product development and...
FDA approves Astellas Pharmas Veozah (fezolinetant), an oral drug for treating moderate-to-severe vasomotor symptoms caused by menopause.
Due to its authority having expired on 5/11 with the end of the Covid-10 public health emergency (PHE), FDA now urges medical device makers to maintai...
FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray for treating severe...
FDA eases its recommendations for evaluating potential blood donors for HIV.
FDA says a Cook Medical 4/7 recall of a tracheostomy introducer is Class 1.
FDA approves an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpriprazole) oral tablets for treating agitation associated with d...
Three stakeholder groups and seven individuals call for FDA to promptly approve a Knowledge Ecology International 2020 petition to ban music in DTC ad...
