FDA passes on holding an advisory committee meeting to review a Tonix Pharmaceuticals NDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for ...
FDA awards Secretome Therapeutics a fast track designation for STM-01, the companys neonatal cardiac progenitor cell therapy for treating certain pat...
FDA clears a Tenon Medical 510(k) for an expanded indication for the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion.
Bard Peripheral Vascular updates the instructions for use (Class 1 recall) for its Rotarex Atherectomy Systems after receiving reports about the helix...
FDA delays again a final rule entitled Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU) to allow the Trump Adm...
HLB and Chinas Antengene say FDA has issued a second complete response letter on rivoceranib and its use in combination with camrelizumab for treating...
Former FDA principal deputy commissioner and second-in-command Namandj Bumpus joins the board of Recursion, a Tech/Bio company that looks to decode bi...
FDA approves a Johnson & Johnson supplemental BLA for Tremfya (guselkumab) and its use in treating adults with moderately to severely active Crohns di...
