Food and Drug Administration (FDA)
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Shares of Protagonist Therapeutics climbed nearly 4% in premarket trading after the company announced its lead drug candidate rusfertide snagged Breakthrough Therapy Designation from the U.S. FDA.
The new approval for Cosentyx marks the first for a pediatric patient population in the U.S. Here’s everything you need to know about this new drug from Novartis.
The newly approved drug, Lybalvi, is a once-daily oral antipsychotic drug that is both a maintenance monotherapy or for the acute treatment of manic or mixed episodes.
The FDA approves Truseltiq for patients with previously-treated locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.
The FDA gave the green light to Amgen’s Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
The latest news in COVID-19 includes support for an investigation into the origins of the virus, a new naming system, and legal discussions of whether employers can mandate vaccination.
The U.S. FDA is starting off the summer months with a busy week after the Memorial Day holiday in the U.S. Here’s a look.
The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
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