Former Advanced BioHealing chairman and CEO Kevin Rakin pays the government $2.5 million to settle False Claims Act allegations that he knowingly allo...
FDA releases a 3/14 Warning Letter to Pharmasol after conducting two 8/2018 facility inspections at South Easton, MA and Stoughton, MA, and citing sig...
FDA approves two new methods for administering GlaxoSmithKlines Nucala (mepolizumab) an autoinjector and a pre-filled safety syringe for patients wi...
The Federal Trade Commission implements electronic filing to replace hard-copy submissions involving brand name and generic drug company agreements fo...
FDA approves a PTC Therapeutics supplemental NDA for Emflaza (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy...
FDA clears an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal ...
Insys Therapeutics agrees to pay $225 million and participate in an enhanced corporate integrity program to resolve civil and criminal charges involvi...
FDA announces that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through CDERs NextGen Portal.