Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer's treatment lecanemab a few months after rejecting ...
News Medical1d
Study identifies a potential treatment for Sandhoff and Tay-Sachs diseases
In a groundbreaking study, researchers at McMaster University have identified a potential treatment for Sandhoff and Tay-Sachs diseases—two rare, often fatal lysosomal storage disorders that cause ...
News Medical1d
MaxCyte celebrates 25 years of innovation driving cell engineering-based therapeutics
MaxCyte, Inc., a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, ...
Marketplace15d
The U.K.’s budget gets the IMF’s seal of approval
From the BBC World Service: The Labour Party's budget includes a $50 billion tax hike to fund public services. Our weekly “Econ Extra Credit” newsletter is an unexpected way to learn about the ...
Roll Call16d
Appeals court hears drugmaker’s challenge to abortion restrictions
The FDA approved mifepristone in 2000 and GenBioPro’s generic version in 2019. Abortion opponents have repeatedly challenged regulations to and the approval of the drug. In June, the Supreme ...
Deadline.com19d
Lizzo Shares In ‘South Park’ Joke With New Halloween Costume “LizzOzempic”
Try Lizzo!” and “Lose guilt, gain confidence.” The photo, which features the pop-rap phenom in a “FDA-approved” medicine carton cinched with a tape measure, includes various disclaimers ...
Food Safety News20d
FDA increases import restrictions for illegal colors, misbranding and more
The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Use the chart below to view import alerts.
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 ...
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 ...
FiercePharma21d
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 ...
Morningstar21d
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 ...