FDA approves an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for trea...
A Tufts Center for the Study of Drug Development analysis shows that development time for orphan drugs is significantly longer than for all new drugs ...
FDA issues a question-and-answer document on microsampling as part of the assessment of systemic exposure in toxicity studies.
FDA issues a draft guidance for sponsors developing drugs to treat uncomplicated urinary tract infections.
Harvard Medical School researchers Michael Sinha and Arnold Kesselheim say advocates of reduced government oversight of off-label drug promotion are t...
FDA clears a Prisyna 510(k) for its Moisyn product designed to treat xerostomia (dry mouth).
Federal Register notice: FDA establishes a public docket to assist with its development of a policy/guidance document on assessing drug-drug interacti...
CDER director Janet Woodcock says the practical effect of granting a drug candidate breakthrough therapy designation is that the drug and its sponsor ...