FDA grants Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran and its use in treating myotonic dystrophy Type 1.
FDA reminds healthcare providers and facilities about the agencys continuing safety and quality concerns with some Getinge/Maquet cardiovascular medic...
FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Executive Order.
FDA grants in part and denies in part a 14-year-old Kaiser Permanente petition on the development, implementation, and evaluation of REMS.
FDA grants China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for treating esophageal can...
FDA warns Dr. Kevin Bender, doing business as DBC Research in Tamarac, FL, about violations in his conduct of clinical trials.
Endo is ordered to pay $1.85 billion in fines and forfeitures after pleading guilty to introducing misbranded Opana ER into interstate commerce and cl...
Six Hogan Lovells attorneys comprehensively analyze the new FDA final rule on laboratory-developed tests and predict industry stakeholder litigation c...
