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The FDA outlined when sponsors can seek waivers, reductions or refunds of Prescription Drug User Fee Act (PDUFA) fees, in a final guidance released on Wednesday. Read More
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 evidence suggesting Tecentriq plus nab-paclitaxel extends the time before the disease worsens by 2.5 months compared to placebo plus nab-paclitaxel is “unreliable,” NICE found. Read More
The novel delivery mechanism could make MAT2203 a valuable treatment for invasive fungal infections like cryptococcal meningitis, the company says. 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
In other countries, drug prices can be 50 to 60 percent lower in some cases for “the exact same pill, from the exact same factory, from the exact same company,” despite the U.S. footing the research and development bills, Trump said. Read More