An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep drug Hetlioz (tasime...
A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS secretary Robert F. Ke...
Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger...
FDA announces a two-day virtual public workshop to address methodological challenges in using patient experience data in drug development and regulato...
FDA grants Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associated steatohepatitis.
Tonix Pharmaceuticals gains approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treating fibromyalgia in a...
Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics NUZ-001 and its use f...
FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that ...
