The FDA granted regenerative medicine advanced therapy designation to 4D-150 for the treatment of diabetic macular edema, ...

To REMS, or not to REMS. That, apparently, was the question for Cytokinetics, which has seen any potential approval for its ...

Over the next four months, the Vaccine Integrity Project will hold information-gathering sessions with medical associations, ...

The New York-based public benefit corporation is advancing three drug candidates for the extremely rare condition.

A group of expectant moms sized up some new walking shoes ahead of the holiday this week as part of an ECU initiative to improve maternal and child health in the region. The shopping trip to Fleet ...

In a separate development Thursday, the FDA suspended a quality control program that ensured its network of 170 labs across the country returned consistent, accurate results.

Unfortunately, a program that already exists at the federal level, designed to lower drug costs and improve access to medication for low-income Americans, has been corrupted. The 340B federal drug ...

The user fee program involves agreements where pharmaceutical and generic drug companies finance the FDA’s review of their products. These agreements are supervised by Congress. The dismissals have ...

The FDA has suspended its Food Emergency Response Network's proficiency testing program due to significant staff cuts at the Department of Health and Human Services. This affects the quality control ...

The FDA approved dupilumab (Dupixent ... president and CEO of the Asthma and Allergy Foundation of America, in a statement. "The approval of this treatment offers patients more options and ...