Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...
Woman, 23, warns about common contact lens mistake after going blind in one eye
It happens when a parasite that can be found in water invades the eye, damaging the cornea, causing severe pain and ...
Voice of America20d
US approves $2 billion arms sale to Taiwan including Ukraine tested missile system
The United States has approved a potential $2 billion arms sale package to Taiwan, the Pentagon said on Friday, including the delivery for the first time to the island of an advanced air defense ...
MarketWatch20d
Pfizer wins FDA approval for hemophilia B drug that will be first once-weekly treatment
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 ...
ENDPOINTS NEWS20d
Iterum wins ap­proval for new oral an­tibi­ot­ic for UTIs. Now it wants a part­ner
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 ...
Reuters20d
US FDA approves Iterum's treatment for urinary infection
2024 Healthcare & Pharmaceuticalscategory US FDA approves Johnson & Johnson's device for heart condition November 7, 2024 Healthcare & Pharmaceuticalscategory Americans hungry for weight-loss ...
FiercePharma20d
After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
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 ...
Electrek20d
In a first, US approves massive new lithium mine in Nevada
The US government has approved the construction of a massive new lithium mine on public land in Nevada as part of a strategy to break China’s dominance over the supply chain of critical minerals ...
Morningstar21d
Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAHâ„¢ (Oral Sulopenem) for the Treatment of 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 ...
MedPage Today21d
FDA Approves Novel Treatment for UTIs
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 ...
medtechdive21d
Medtronic wins FDA approval for Affera mapping and ablation system
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 ...