After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge ...

The first phase of the U.K. synthetic human genome project has successfully completed, realizing key steps in chromosome ...

Individual liberty and choice vs. wider public health became one predictable hinge upon which swung the often-acerbic debates at the CDC’s Advisory Committee for Immunization Practices (ACIP) meeting, ...

Natera Inc. completed the acquisition of Foresight Diagnostics Inc. in a deal structured as $275 million up front plus contingent payments of up to $175 million based on achieving certain milestones ...

Saluda Medical Pty Ltd. announced a AU$231 million ($152.7 million) initial public offering on the Australian Securities ...

Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects ...

Laigo Bio BV has raised €11.5 million (US$13.7 million) in a seed round for the further development of a new approach to ...

Drug developers big and small are pursuing a solution for the curse of psychosis that occurs along with the already tragic ...

The U.S. FDA granted accelerated approval for the Biologics License Application for Axogen Inc.'s Avance, an acellular nerve ...

A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow ...

The BioWorld Neurological Diseases Index continued the recovery noted at the end of August, closing November with a gain of 2.64%.

One of the sessions at this year’s Food and Drug Law Institute’s enforcement conference dealt with the use of AI for FDA compliance activities, but the question of AI legislation also arose. The ...