The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...

Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up ...

Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or ...

Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...

Paediatric patients with narcolepsy will now have access to Avadel’s Lumryz (sodium oxybate) after the US Food and Drug Administration (FDA) approved a supplemental new drug application.

which should help the substances make it through the separate FDA approval process. Brooks said PFI is not opposed to AAFCO's proposed state-level replacement, but does have "a ton of questions ...

FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.

(RTTNews) - Iterum Therapeutics plc (ITRM) Friday announced that the U.S. Food and Drug Administration (FDA) has approved Iterum's new drug application for Orlynvah (sulopenem etzadroxil and ...

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for ... of ORLYNVAH™ and Iterum’s strategic process to sell, license, or otherwise ...