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FDA Commissioner Scott Gottlieb announced on Thursday that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone. Read More
Aimovig is the first treatment that targets the process caused by proteins in which blood vessels in the brain swell and lead to migraine symptoms. Read More
“Specific statutes grant the state and federal government authority to bring these kinds of suits without meeting the ordinary burdens of individual civil plaintiffs,” the judge said. Read More
Allergan and the St. Regis Mohawk Tribe have asked the Supreme Court to reverse a federal appeals court’s decision to bar a controversial tactic from being used as patent protection against inter partes reviews (IPRs). Read More
An FDA advisory committee on Wednesday approved the risk-benefit profile of Amgen’s romosozumab, a monoclonal antibody for treatment of osteoporosis. Read More
As the partial government shutdown grinds on, the FDA resumed issuing guidance on Wednesday with a revised draft guidance to help sponsors of rare disease treatments conduct more effective clinical trials. Read More
The FDA released draft guidance Wednesday for companies seeking amendments or final approval for tentatively approved ANDAs — the first guidance to emerge during the partial government shutdown. Read More