Concert Pharmaceuticals' just-started phase 2a trial of its baldness candidate CTP-543 has been halted by an FDA request to look at preclinical toxicity…

The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in 6 months or less.

AstraZeneca EVP Mene Pangalos has laid out how he wants the next government to support the United Kingdom’s life sciences sector through Brexit.

AstraZeneca's European pharma VP is reported to be on "gardening leave" after his employer sues for breaching his employment contract.

New FDA Commissioner Scott Gottlieb delivered his first address to agency workers yesterday, and tackling high drug prices featured prominently in the speech.

Analysts have torn into AB Science over the clinical trial compliance failings identified by regulators in France.

The FDA has sent a warning letter to a trial site studying Ionis Pharmaceuticals’ IONIS-TTRrx.

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…

Regulatory