Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues ...

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans' health.

Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is ...

Opinion How we plan to cut FDA drug approval time by months Qualifying manufacturers will be able to submit some data while clinical trials are ongoing.

It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

To be eligible for the FDA’s new Commissioner’s National Priority Voucher program, a drug must meet certain national health interests. Qualifying medicines could be reviewed in one to two ...

Human organs-on-chips and organoids offer new alternatives to animals for drug development, but there is still a long way to ...

(NYSE:JNJ) announced today that the FDA granted priority review to a new drug application (NDA) for its TAR-200.

Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures.