FDA grants Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients with newly-diagnosed gl...
Attorney Mark Schwartz outlines three possible scenarios to resolve the current pause in FDA foreign manufacturing facility inspections.
FDA is giving priority review to a Merck/Bayer NDA for vericiguat to treat some chronic heart failure patients.
Federal Register notice: FDA makes available a draft guidance on using data from foreign investigational studies in new animal drug applications.
A CDRH Webinar discusses methods for decontaminating N95 masks for re-use and agency guidance on decontamination.
Hogan Lovells attorneys say FDA authority to approve biosimilars under the BPCIA could end if the Supreme Court throws out the Affordable Care Act and...
An FDA advisory committee provides a mixed vote (8 to 7) in favor of approval for Mallinckrodts terlipressin and its use to treat adults with hepatore...
FDA clears a Clinical Computer Systems 510(k) for the Obix BeCA fetal monitor.