A trio of drugmakers are treading…
A trio of drugmakers are treading the boards to raise [...]
The latest untitled letter from…
The latest untitled letter from the FDA’s Office of Prescription [...]
Theresa Michele, the director of…
Theresa Michele, the director of the Office of Nonprescription Drugs [...]
The FDA has placed a hold on…
The FDA has placed a hold on Denali Therapeutics’ plans [...]
Crescent Biopharma has agreed to…
Crescent Biopharma has agreed to pay Kelun-Biotech $80 million for [...]
While Denali Therapeutics awaits a…
While Denali Therapeutics awaits a delayed FDA decision for its [...]
The FDA has named Tracy Beth…
The FDA has named Tracy Beth Høeg, M.D., Ph.D., as [...]
Former F.D.A. Commissioners Sound Alarm on Plan to Change Vaccine Policy
Twelve former commissioners, in a New England Journal of Medicine [...]
The FDA has proposed cutting fees…
The FDA has proposed cutting fees for early-stage companies conducting [...]
Cosmo Pharmaceuticals has revealed…
Cosmo Pharmaceuticals has revealed topline results from two phase 3 [...]