Moderna is asking FDA for an emergency use authorization for its Covid-19 vaccine in children aged 6 months to 6 years old.
Lilly says its investigational weight-loss drug tirzepatide met all endpoints in the 72-week SURMOUNT-1 trial.
FDA lifts a clinical hold on Pfizers mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrop...
Retired Ethicon quality engineer Eric Hinrichs says medical device project design teams must document all risk assessments and how the risks have been...
A House Committee on Oversight and Reform hearing sharply criticizes consulting firm McKinsey and Co. for its role in advising Purdue Pharm during the...
PhRMA cites FDA statistics to support its position that the Federal Trade Commission and Department of Justice dont need new ways to evaluate how drug...
FDA says Pfizer is recalling five lots of Accupril due to the presence of a nitrosamine above the acceptable daily level.
FDA says it is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorizat...