FDA publishes a report with charts of bioresearch monitoring inspections from FY 2017.
FDA issues Evolus a complete response letter on its BLA for potential Botox competitor DWP-450 (prabotulinumtoxinA) for treating glabellar lines.
FDA accepts for review an Insmed NDA for ALIS (amikacin liposome) inhalation suspension for adult patients with nontuberculous mycobacterial lung dise...
The federal government intervenes in five whistleblower suits against Insys Therapeutics over improper payments to healthcare professionals to induce ...
FDA clears a MC10 510(k) for its BioStamp nPoint system, a wireless, biometric data collection platform intended for use by healthcare professionals a...
FDA researchers highlight the varying participation rates of women in various types of cardiovascular clinical trials.
FDA approves a U.S. WorldMeds NDA for Lucemyra (lofexidine hydrochloride) for mitigating withdrawal symptoms in adults who have abruptly discontinued ...
IQVIA, an FDA data vendor, says it has corrected a weight-conversion factor problem identified by FDA in data on fentanyl sales.