The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the impact of mass layoffs at the FDA, impact on ...

The pharmaceutical industry's next billion-dollar blockbuster won't come from a lab alone—it will come from listening to ...

Scale-up is a common problem encountered in all forms of development across industries, and oral solid dose manufacturing ...

Combining Trodelvy with Keytruda and pushing it into the frontline setting could “potentially double” the ADC’s market in ...

Andrei Georgescu of Vivodyne discusses key advantages of its humanized drug testing platform and the impact of the FDA’s policy shift.

When the Trump administration cut more than $11 billion in COVID-era funds to states, addiction recovery programs suffered swift losses.

Gilead Sciences said a combination of its cancer drug Trodelvy and Merck’s Keytruda delayed the growth of tumors in women ...

The move comes after lawmakers sought to force the agency to update regulations that would allow alternatives to animal ...

Breakthrough research could make any IV drug able to be taken orally for a range of hard-to-treat cancers and other diseases, and redefine how medicines are designed, evaluated and delivered.

Biotech companies developing drugs for hard-to-treat diseases and other ailments are being forced to push back clinical trials and drug testing in the wake of mass layoffs at the Food and Drug ...