FDA issues complete response letters for two Celltrion biosimilars following a Warning Letter for CGMP problems at the firms Incheon, Korea, plant.
FDA commissioner Scott Gottlieb says doctors are often prescribing more opioids that patients are likely to need and more provider education and evide...
Two attorneys say that a 3rd Circuit Appeals Court False Claims Act decision reiterates that an actual false claim linked to the defendants actions is...
FDA accepts for priority review two Paratek Pharmaceuticals NDAs for omadacycline, an investigational once-daily oral and intravenous broad spectrum a...
Federal Register notice: FDA seeks comments on the drug industrys use of exposure-response analyses, particularly as it relates to recommendations in ...
Federal Register notice: FDA makes available a guidance entitled Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetic...
FDA clears a Sonoma Pharmaceuticals 510(k) for an antimicrobial post-therapy gel, intended for use in managing post-non-ablative laser therapy procedu...
FDA accepts an Antares Pharma NDA resubmission Xyosted (testosterone enanthate) injection for testosterone replacement therapy.