Pfizer says that its Phase 3 CIFFREO placebo-controlled study evaluating an investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec...
Federal Register notice: FDA issues an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a person that has an ...
Federal Register notice: FDA issues an order debarring Richard B. Smith III for five years from importing or offering for import any drug into the U.S...
CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the Emerging Drug Safety Technology Meeting program that offers acc...
FDA says it has issued a final report from the Drug Supply Chain Security Act pilot project.
FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioanalytical method valid...
FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyrosine receptor kinas...
Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned during electrosurgery ...
