As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress.

The FDA has accepted the New Drug Application for doravirine/islatravir for adults with virologically-suppressed HIV-1 infection.

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...

Milestone ® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in the ...

If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, according to the Merck news release.

Jeneen Interlandi, a domestic correspondent for Opinion and a staff writer at the magazine, writes frequently about public ...

For the second time in under 3 weeks, the FDA has approved a treatment for the inherited genetic disorder characterized by recurrent episodes of severe swelling.

The FDA has granted priority review to an application for Revuforj for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia.

Researchers Suggest User Fees Could Help FDA Ensure Food Safety The U.S. Food and Drug Administration already collects user fees from drug and medical device companies, as well as accreditation and ...