FDA approves Pfizer’s first gene therapy for rare inherited bleeding disorder
The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B.
CNN1mon
FDA approves new drug that may help stop a rare, fatal condition that doctors call a ‘ticking time bomb’
Then her medical team offered her a potential lifeline: a first-of-its-kind experimental drug called sotatercept that corrals a growth factor that is overproduced by people with PAH, potentially ...
MedPage Today5d
New Targeted Drug Approved for Low-Grade Glioma in Kids
It represents the first systemic therapy for pediatric low-grade gliomas harboring BRAF rearrangements, or fusions, according ...
The American Journal of Managed Care23d
FDA Approves Cilta-Cel for Earlier Treatment of RRMM
Carvykti is the first and only BCMA-targeted treatment approved by the ... multiple-myeloma-302090580.html 4. Caffrey M. FDA approves cilta-cel to treat R/R multiple myeloma.
Becker's Hospital Review4d
FDA approves treatment for uncomplicated UTIs
The approval for Pivya was given to Utility Therapeutics, a U.S. company that acquired the rights to the drug. It is expected to become available in 2025. In clinical trials, Pivya outperformed ...
U.S. News & World Report4d
FDA Approves New Antibiotic Against UTIs
So, it's welcome news that the U.S. Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to fight bacterial UTIs. "UTIs are a very common condition impacting women and one of ...
Forbes26d
FDA Approves AI Tool That Can Detect Sepsis
The Sepsis ImmunoScore uses 22 diagnostic and predictive parameters to calculate the risk of a patient developing sepsis within 24 hours, a criteria combination that has “never previously been ...
The New York Times5d
F.D.A. Approves Antibiotic for Increasingly Hard-to-Treat Urinary Tract Infections
By Andrew Jacobs The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful ...
Reuters26d
US FDA approves Vanda's drug for treatment of bipolar disorder
opens new tab drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment. Shares of the ...
MedPage Today21d
FDA Approves Earlier Use of CAR-T Products for Myeloma
Share on Facebook. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA expanded the labels of two CAR T-cell products for ...
The Washington Post25d
In a first, FDA authorizes AI-driven test to predict sepsis in hospitals
Now, the Food and Drug Administration has greenlighted such a test developed by Reddy’s company, Chicago-based Prenosis, to predict the risk of sepsis — a complex condition that contributes to ...
The Washington Post3d
Medtronic wins FDA approval for adjustable spine-pain implant
Medtronic said Friday that the U.S. Food and Drug Administration has approved a new spinal-cord implant that relieves chronic pain, a bid to expand into a patient population that relies heavily on ...