As expected, Scott Gottlieb, M.D., has been confirmed as the new head of the FDA, about four months after his Obama-picked predecessor Robert Califf stepped…

Biotech billionaire Patrick Soon-Shiong has been through the media wringer in the last few months, so will welcome an FDA green light that will draw attention…

The FDA has rejected a filing for approval of TherapeuticsMD’s treatment for vaginal pain during sexual intercourse because of the lack of 12-month safety data…

Biotech executives and the head of the NIH are set to meet with top White House officials today.

Regulus Therapeutics has axed 30% of its workforce to conserve cash for its stuttering pipeline.

Two months ago, Accera registered a late-stage flop for its much-derided “brain food” candidate AC-1204 in Alzheimer’s, but now the company is looking to…

Sunesis Pharmaceuticals has been forced to concede defeat in its bid to bring vosaroxin to the E.U. market for acute myeloid leukemia.

Atlantic Healthcare has started a rolling submission for its antisense inflammatory bowel disease drug alicaforsen enema.

President Trump's push for a reduction in the NIH budget came to nothing last night as Congress instead increased it by $2 billion.

Regulatory