FDA issues a draft guidance on how drug supply chain trading partners can request a waiver, exception, or exemption from some specified requirements.
FDA approves a Janssen supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for treating patients w...
A new FDA letter to healthcare professionals provides recommendations about patient selection and the use of neurovascular stents used for stent-assis...
Attorney Victor Schwartz says Massachusetts highest court allowed a reckless liability claim against Merck even though the plaintiff was injured by a ...
FDA says it should respond by 8/19 to a Rockwell Medical submission seeking a contract manufacturer for its approved generic drug Calcitriol.
Attorney Bradley Thompson urges the medical device industry to weigh the downstream consequences of unbridled enthusiasm for FDAs proposed software pr...
FDA approves a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia.
FDA releases its latest batch of Warning Letters that includes Biotek Inc. and Dexcowin Co.