After determining inadequate recall notifications to date, FDA issues a rare Section 518(a) notification order to Philips Respironics requiring the co...
FDA removes an Immunome clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19 after the company provided more therapy preparation ...
A federal judge sentences James Boccuzzi of Parkland, FL, a former sales director for Blackstone Labs, to 51 months in prison for conspiring to defrau...
Venatorx Pharmaceuticals plans a fourth quarter NDA submission following positive results from its pivotal Phase 3 study evaluating cefepime-taniborba...
FDA says it will act on 8/4 on an Acadia Pharmaceuticals resubmitted sNDA for Nuplazid to treat hallucinations and delusions associated with Alzheimer...
A California federal judge approves a $3.65 million settlement between the defunct StemGenex stem cell clinic and 1,063 former clients who said they w...
Sen. Charles Grassley calls on the Federal Trade Commission to overcome a deadlocked vote and initiate a study into the business practices of pharmacy...
Federal Register notice: FDA makes available a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certa...