Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from ...
After many months of uncertainty related to the Biosecure Act and associated security efforts in Washington, D.C., Chinese ...
The Centers for Disease Control and Prevention's (CDC’s) newly reworked Advisory Committee on Immunization Practices (ACIP) ...
One day after the FDA’s new director of the Center for Drug Evaluation and Research (CDER), Richard Pazdur, M.D., informed ...
A trio of drugmakers are treading the boards to raise awareness of global antimicrobial resistance (AMR). | A trio of ...
The latest untitled letter from the FDA’s Office of Prescription Drug Promotion zeroes in on a patient testimonial video ...
The Buckland Group launched Quvara Medical as the newest CDMO to debut this year after buying a former Becton Dickinson manufacturing site in the U.K. for an undisclosed price. | The Buckland Group ...
Cosmo Pharmaceuticals has revealed topline results from two phase 3 trials which indicate that its topical cream clascoterone ...
Daiichi Sankyo has emerged victorious in appeals court, flipping a prior multimillion-dollar patent verdict on its head and ...
As the U.S. focuses on beefing up its biopharma manufacturing infrastructure this year, a similar effort toward improved drug ...
With both a label expansion and a conversion to a full approval, Eli Lilly has earned the FDA’s go-ahead to act on the ...
The phase 3 comeback story Bristol Myers Squibb investors were eagerly anticipating is not to be—at least not this year. | ...