Regulatory
The U.S. Food and Drug Administration (FDA) granted vTv Therapeutics’ TTP399 Breakthrough Therapy designation for type 1 diabetes. This designation provides companies more support and the possibility of shorter development and review timelines.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 13, 2021.
The U.S. CDC and the U.S. FDA have identified six cases in the U.S. of a “rare and severe” type of blood clot, which seems to be linked to the COVID-19 vaccine by Johnson & Johnson.
The U.S. Food and Drug Administration (FDA) approved a prefilled syringe for self-injection of an allergic diseases treatment developed by Novartis and Genentech, a Roche company.
The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.
The story of how the Ervebo came to be is not just an account of a broken contract, but also a cautionary tale.
The agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more previous system therapies, at least one for metastatic disease.
The action data was extended by the agency to provide more time to review new data analyses submitted by Lilly, per information requests made by the FDA.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 6, 2021.
Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.
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