FDA grants Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer.
Rated Class 1 by FDA, Cordis recalls its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns.
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...
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...
