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.
Janssen Biotech submits an emergency use authorization application for its single-dose Covid-19 vaccine candidate.
The 4th Circuit affirms summary judgment granted to Greer Laboratories in a whistleblower case involving custom allergenic extracts.