A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Travere Therapeutics recently reported that the FDA has extended its review of the supplemental New Drug Application for ...

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

Travere Therapeutics shares fall after the FDA extends its review timeline for Filspari's sNDA in FSGS, pushing the decision ...

MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.

6 min read | UniQure secured a Type A FDA meeting, a high-priority discussion for urgent issues. Within 30 days, both sides will discuss what kind of data package might support the advancement of ...

The FDA postponed reviews for two drugs in the Trump administration's fast-track program due to safety and efficacy concerns.

A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...