The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

In this episode of Denatured, BioSpace's Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter ...

The Alliance for Regenerative Medicine has voiced deep disappointment about reports that the FDA has put the director of its ...

In an historic milestone for food safety and nutrition, Tamarack Biotics secured U.S. FDA acceptance for its novel light-based milk treatment process. This clears the way for a new generation of dairy ...

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...

Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her ...

The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported ...

The approval could slow new infections and move the world closer to eliminating HIV. But huge obstacles remain.

A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. One ...

Press Release DESKi, a healthtech company developing AI-powered diagnostic tools in collaboration with clinicians and researchers, today announced the close of a $6 million seed round to support the U ...

Yeztugo, a twice-a-year antiviral shot to prevent HIV, was approved by the Food and Drug Administration on Wednesday, marking ...