In preparation for a 7/15 FDA advisory committee meeting to consider a FibroGen NDA for roxadustat, the company clarifies some of its trial data invol...
CBER cautions Curex, Inc., New York, NY, that it is unlawfully marketing and distributing allergy drops and drop compounds.
FDA warns RPK Pharmaceuticals about a listing discrepancy for a drug cream it manufactures.
The 9th Circuit Court of Appeals reverses part of a California federal court decision that dismissed all whistleblower claims against Medtronic over t...
The Biden Administration shows no signs of moving to nominate an FDA commissioner, which could leave current acting commissioner Janet Woodcock at the...
FDA releases the FDA-483 issued following an inspection at the Wells Pharmacy, Dyersburg, TN, outsourcing facility.
Troutman Pepper attorneys say FDA is continuing action against companies claiming health benefits for CBD products.
Former FDA lawyer Sonia Wadhwa Nath joins Cooley as a partner in the law firms business litigation and healthcare regulatory practice groups based in ...