Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Dr. Marty Makary tells CBS News' Norah O'Donnell in an exclusive interview why the agency decided to drop decades ...

"The stories are so outrageous," Senator Ron Johnson said. "It just appears that they’re looking for excuses to say no." ...

UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for FDA approvals in multiple myeloma.

The Food and Drug Administration is taking a closer look at kratom extracts and preparing to ask Congress for expanded authority to shut down illegal vaping imports, according to the agency’s head. In ...

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...

President Trump’s Food and Drug Administration is cracking down on the “endless” barrage of pharmaceutical advertisements Americans are hit with on a daily basis, FDA Commissioner Marty Makary said on ...

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle ...