The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human ...
ImmunityBio stock rose 19.8% after FDA meeting on ANKTIVA bladder cancer treatment. Company to submit additional data within ...
The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, yet other leading pharmaceutical companies are hesitating over what ...
Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...