Food and Drug Administration (FDA)
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National Cancer Institute Director Norman “Ned” Sharpless will take over the role as acting commissioner of the FDA while the White House seeks a permanent replacement for the outgoing Scott Gottlieb.
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
The president’s proposed spending plan cuts $4.5 to $5.5 billion from the current budget of the National Institutes of Health, about an 11 percent decrease from 2019.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication.
The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars—the branded drug’s name and a unique, four-letter suffix—made the drugs sound inferior to consumers than their branded counterparts.
Perhaps the biggest mover and shaker announcement this week was the unexpected resignation of Scott Gottlieb, commissioner of the U.S. Food and Drug Administration. Gottlieb will leave his post later this month to spend more time with his family.
Gottlieb announced his intention to leave the FDA earlier this week. The Trump administration will have a list of candidates to choose from as it moves forward.
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