In an untitled letter issued in March, the regulator declared all in vitro data generated by CRO Raptim Research as ...

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us ...

AbbVie told Stat that it had stopped airing the ad after the first half of the year and that it is complying with the FDA's investigation. So-called 'untitled letters' from the FDA for advertising ...

The recent warning and untitled letters have demonstrated that the FDA is reviewing websites and social media to find instances of non-compliant advertisements. Not following FDA regulations can ...

The FDA has not published more than a dozen letters that flagged hazards at food companies, including potential contamination ...

99% 12-month and 96% 36-month disease-specific survival in papillary NMIBC without CIS. 10-year cystectomy-free status observed in long-term follow-up of Phase 1 trial. Don’t miss this list of 3 ...

Investing.com -- Shares of ImmunityBio, Inc. (NASDAQ:IBRX) fell 9% following the company’s announcement that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration ...

The FDA has slapped Empower Pharma with a warning letter citing a laundry list of production issues that put the company in violation of its 503B compounding credentials under the Federal Food ...

Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for bladder ...