A House Appropriations subcommittee votes to approve a fiscal year 2019 spending bill that would give FDA a $308 million (10%) boost above the current...
Pacira Pharmaceuticals petitions FDA not to approve any NDA for a fixed-dose combination of bupivacaine and meloxicam without sufficient evidence of s...
FDA issues a draft guidance on how drug supply chain trading partners can request a waiver, exception, or exemption from some specified requirements.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...