After three months without a permanent leader in place, President Donald Trump looks set to name a new commissioner of the FDA. Heidi Overton, M.D., Ph.D., currently a White House aide, will go before the Senate in an effort to secure the job of the country’s top drug regulator, based […]

For the first time, SK Biopharmaceuticals has reached a settlement with a generics manufacturer who has applied for FDA approval of a copycat version of its epilepsy treatment Xcopri, local news outlets report. SK’s deal with India’s MSN Laboratories will allow the Korean company to extend its market exclusivity beyond […]

After receiving a checkered regulatory scorecard in 2024, Aurobindo’s sterile injectables and oncology unit is back in the FDA’s crosshairs.

The summer of the high-potency active pharmaceutical ingredient expansion continues, as yet another manufacturing specialist makes inroads to boost capacity for the sensitive and in-demand drug ingredients.

Genetix Biotherapeutics is teaming up with the NFL Alumni Association for a U.S. awareness and education drive centered on sickle cell disease.

Revance has appointed Ulta Beauty and Procter & Gamble alum Janelle Wichmann as its new chief marketing officer, skincare as it looks to boost commercial penetration of its Botox rival Daxxify.