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 Medical22h
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 ...
Le Lézard1d
Implantica submits FDA PMA application Clinical Module 2 for RefluxStoptm for U.S. market approval
The second module submitted earlier this week for the RefluxStoptm PMA is the most crucial module of the three-module process for FDA approval. The outcome of our clinical study submitted to FDA shows ...
News Medical1d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...
Business Insider3d
Ocular Therapeutix™ Appoints Namrata Saroj, OD, as Chief Business Officer
BEDFORD, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through ...
Marketplace14d
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 ...
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 ...