In Thursday's meeting, the director of the FDA's Center for Drug Evaluation and Research said plans for coming layoffs were ...
Should Marty Makary take the reins at the FDA, transitioning from gadfly to the head of an agency that regulates a fifth of ...
According to the agency, the 15-year-old company only presented efficacy claims for its branded medication and did not include any warnings or precautions for the tablets at a tradeshow.
The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles they will face on Monday when they return to their offices en mass as ...
Researchers here described how they were able to safely and ethically enroll adolescents in a landmark trial of a drug that ...
References: Neurotech’s Encelto™ (revakinagene taroretcel-lwey) approved by the FDA for the treatment of macular telangiectasia type 2 (MacTel). News release Neurotech Pharmaceuticals.
Recent FDA feedback received on SER-155 allogeneic hematopoietic stem cell transplant (allo-HSCT) next study provides support for the proposed ...