FDA names Stanford pediatrics adjunct professor George Tidmarsh, an industry veteran for over 30 years, as the new CDER director.
Integra LifeSciences recalls (Class 1) its MicroMyst Applicators due to incomplete bioburden assessments and incomplete sterilization location transfe...
Sarepta brushes off an informal request from FDA to voluntarily halt shipment of Elevidys (delandistrogene moxeparvovec), a gene therapy for Duchenne ...
Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clinical trials.
Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate compliance measurem...
An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (delandistrogene moxeparvov...
FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.
SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.
