Government
BMS accused Kite and Gilead of copying the research conducted at Memorial Sloan Kettering to push the development of Yescarta.
The FDA approved extended-release 11 mg and 22 mg tablets as a once-daily treatment from the chronic inflammatory condition.
The U.S. Food and Drug Administration is wrapping up 2019 with a few PDUFA dates. Here’s a look.
The U.S. Senate confirmed Hahn as the new commissioner Thursday in a 72-18 vote.
House Speaker Nancy Pelosi’s drug pricing reform bill passed the House of Representatives in a mostly party-line vote and will now head to the U.S. Senate, where its chances of moving forward in the Republican-led chamber are slim.
The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
The FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does.
The U.S. Food and Drug Administration issued a warning letter to the company for misbranding its opioid addiction medication Vivitrol in promotional materials.
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (cited as the Lower Drug Costs Now Act of 2019), awaits a vote by the House in December.
The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact.
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