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The FDA’s Antimicrobial Drugs Advisory Committee voted 14-2 on Wednesday to support Shionogi’s NDA for cefiderocol lyophilized powder for IV administration to treat complicated urinary tract infection (cUTI). Read More
Jury selection began on Wednesday in the Northern District of Ohio for the nation’s first federal bellwether trial in the opioid crisis, as more defendants scrambled to settle before the trial gets underway on Oct. 21. Read More
The FDA issued a warning letter to Indian API and generics manufacturer Glenmark for multiple violations at its Baddi, Himachal Pradesh plant, including incomplete investigations of complaints. Read More
House Speaker Nancy Pelosi’s controversial bill to lower the nation’s drug prices through direct negotiation will be marked up by the House Education and Labor Committee on Thursday. Read More
UnitedHealth filed suit against 20 generic drugmakers in a Minnesota federal court for allegedly conspiring to fix the prices of more than 100 generic drugs. Read More