FDA approves Cobenfy for adults with schizophrenia
The U.S. Food and Drug Administration has approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride), a first ...
health.wusf.usf.edu14d
Reviewing October's top health headlines: listeria, illegal online pharmacies and more
A neurologist, an internist and an infection control expert join the show to discuss what made news in the health care this past month. "What's Health Got to Do with It?" is a talk program from WJCT ...
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Evolving FDA Accelerated Approval Pathway Suffers Spate of Withdrawals
The FDA’s accelerated approval program has helped shepherd nearly 300 new drugs to the market, providing access to these medicines an average of 3.2 years earlier than with traditional approvals, ...
Washington Examiner21d
Drug dealers use fake online pharmacies and search engine loopholes to sell on Google
Kubapharm.com was issued a warning letter by the FDA on March 30 ... cart without ever asking for a doctor’s prescription. It purports to be an online pharmacy with a staff of “highly ...
FiercePharma23d
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 ...
Business Insider23d
Iterum Therapeutics Gets FDA Approval Of Orlynvah For Treatment Of Urinary Tract Infections
(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 ...
Business Insider23d
Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections
ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for ... of ORLYNVAH™ and other antibacterial drugs, ORLYNVAH™ should be used only to ...
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Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (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 ...
The Hill25d
Novo Nordisk asks FDA to block compounding pharmacies from making Ozempic copycats
Compounded versions of semaglutide are not approved by the FDA, and the agency earlier this month said they can pose a risk to patients. The Alliance for Pharmacy Compounding was quick to note ...