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...
Johnson & Johnson files an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque psoriasis.
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.
Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platforms due to concerns ab...
