Live Action alleges "reckless distribution" of the abortion drug mifepristone, urging the Trump administration to suspend its ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

By Patrick Wingrove Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the ...

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...

The FDA has authorized urcosimod 0.05% for single-patient expanded access, or compassionate use, in a patient with ...

Which officials have the legal authority to sign off on approved drugs is among them ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...