FDA clears a Life Spine 510(k) for the ProLift micro Expandable Spacer System for endoscopic transforaminal and posterior lumbar interbody fusion proc...
FDA issues a Warning Letter to contract testing laboratory Missouri Analytical Laboratories after a May inspection cited significant GMP violations fo...
FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimers Disease.
FDA removes a Protagonist Therapeutics clinical hold on the company's rusfertide clinical tumor-detection studies.
FDA approves an Ocular Therapeutix supplemental NDA to broaden Dextenzas (dexamethasone ophthalmic insert) label to add an additional indication for t...
FDA approves Enzyvant Therapeutics thymus tissue-based product Rethymic for treating pediatric patients with congenital athymia, a rare immune disorde...
Athenex decides to abandon its continued development of oral paclitaxel plus encequidar for treating metastatic breast cancer after meeting with FDA t...
FDA grants Y-mAbs Therapeutics a rare pediatric disease designation for the companys lutetium-labeled omburtamab antibody program for treating medullo...