Obe-cel is the first FDA-approved CAR T-cell therapy for B-ALL without a REMS requirement, based on the FELIX trial's positive outcomes. The FELIX trial reported a 63% complete remission rate ...
Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at ...
Roche (ROG.S), opens new tab said on Friday that the FDA had approved its companion diagnostic test to identify patients who may be eligible for Vyloy. The FDA had previously declined to approve ...
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 ...
A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous communication helps organizations identify and proactively address any ...
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 ...
DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new ...
The FDA approval was based on results from the admIRE trial, a single-arm, investigational device exemption study conducted at 30 US centers. Among 277 patients with drug-refractory, symptomatic ...
2024 Healthcare & Pharmaceuticalscategory US FDA approves Johnson & Johnson's device for heart condition November 7, 2024 Healthcare & Pharmaceuticalscategory Americans hungry for weight-loss ...
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 ...
(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 ...
The FDA thumbs up for Abrysvo comes on top of its original approval in May of 2023 for those 60 and older. Three months later, the U.S. regulator also endorsed Abrysvo for women in weeks 32 ...
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