After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.
Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
The U.S. Food and Drug Administration reviewed several drugs under Priority Review ahead of their PDUFA target action dates scheduled during the week of March 8th, 2020.
Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
In a second research report published this year so far, investigators found that the U.S. Food and Drug Administration (FDA) is approving drugs faster than ever.
January 2020 is not a particularly busy month for Prescription Drug User Fee Act (PDUFA) dates for the U.S. Food and Drug Administration, with only two scheduled for the month.
Shares of Aquestive Therapeutics were up more than 18 percent following approval from the U.S. Food and Drug Administration for Exservan, a treatment for amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted to recommend approval of Shionogi & Co. Ltd.’s investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.