FDA grants a Signifier Medical Technologies de novo request to permit the marketing of a new prescription-only device, eXciteOSA, intended to reduce s...
FDA limits the emergency use authorization for Covid-19 convalescent plasma after evaluating the most recent information available.
Bristol-Myers Squibb wins BLA approval for (Breyanzi) lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory l...
Apotex recalls two batches of enoxaparin sodium injection due to a packaging error resulting in some syringe barrels being mislabeled.
Three Morgan Lewis attorneys analyze a recent FDA guidance on antisense oligonucleotide drugs for patients with severely debilitating or life-threaten...
The Clinical Trial Transformation Initiative spells out eight best practices for Covid-19 treatment trials.
FDA clears a Precision Spine 510(k) for its Dakota ACDF Standalone System for treating degenerative disc disease.
An LA Times op-ed endorses CDER director and current FDA acting commissioner Janet Woodcock as the agencys next leader.