The FDA has approved an ingestible event marker from the privately-held digital health company etectRx, as its rival “digital pill” company Proteus faces financial difficulties. Florida-based ...
There’s no evidence that male enhancement pills can ... Administration (FDA) released a warning about nearly 50 male enhancement and weight loss products (which are not FDA approved) available ...
Gilead Sciences withdrew Trodelvy's FDA accelerated approval for urothelial cancer after the TROPiCS-04 study failed to meet the primary endpoint of overall survival. The TROPiCS-04 study showed ...
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 ...
Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced ... seek approval for an over-the-counter contraceptive pill, with ...
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 ...
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 drug application for ...
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 ...
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 ...
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 ...