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 ...

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 ...

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 U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns ...

The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, ...

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 ...

Real change takes a long time, and when it happens, it must be recognized. The FDA and the NIH have announced their move away ...

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

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.