Aradigm files an NDA for Linhaliq (liposomal ciprofloxacin for inhalation) for treating non-cystic fibrosis bronchiectasis patients with chronic lung ...
Intellipharmaceutics says it will try to resolve concerns raised by FDA advisors about its Rexista abuse-deterrent opioid.
FDA commissioner Scott Gottlieb announces two new CDRH initiatives to develop more appropriate regulatory approaches to digital health products.
Federal Register notice: FDA announces a new organizational structure for the Office of the Medical Products and Tobacco to establish the Oncology Cen...
A Tennessee federal court enters a permanent injunction stopping Crown Laboratories from distributing unapproved and misbranded drugs.
FDA medical reviewers say that the Dynavax Heplisav-B hepatitis vaccine is effective but may have safety issues.
FDA commissioner Scott Gottlieb says the agency will postpone sending reduction-in-force notices to staff who are funded by user fees until 9/30 unles...
A Hyman, Phelps & McNamara petition asks FDA to require an explanatory footnote in the Synergy labeling for Trulance indicating that diarrhea adverse ...