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Pfizer Inc. has won regulatory approval for its hympavzi drug as a treatment for hemophilia A or B without inhibitors — making it the first antitissue-factor pathway inhibitor to be allowed for ...

The FDA has cleared Iterum’s oral an­tibi­ot­ic for cer­tain pa­tients with un­com­pli­cat­ed uri­nary tract in­fec­tions (uUTIs) who have lim­it­ed or no al­ter­na­tive oral op ...

Oct 25 (Reuters) - The U.S. Food and Drug Administration has approved Iterum Therapeutics' (ITRM.O), opens new tab oral antibiotic to treat certain types of bacterial urinary tract infections (UTI ...

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 ...

Friday announced that the U.S. Food and Drug Administration (FDA) has approved Iterum's new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated ...

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades --Company to Host Conference Call on Monday, October 28 th ...

(Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of ...

Medtronic’s single-shot Pulseselect system became the first FDA-approved PFA device in December 2023, but it lacks mapping capabilities or the option to deliver RF energy from the catheter. Affera ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved oral sulopenem etzadroxil and probenecid (Orlynvah) to treat uncomplicated urinary tract infections ...

Oct. 24, 2024 – The FDA has approved a new drug called zolbetuximab designed to attack a novel target that’s in a type of stomach cancer. Marketed under the brand name Vyloy, the drug is to ...