pharmaphorum5d
Jubilation for Biogen, Eisai as FDA says 'yes' to aducanumab
For Biogen, an expensive gamble has paid off, as even with accelerated approval the company stands to make billions of dollars from aducanumab, given it estimates there are around 1.5 million ...
US FDA approves Syndax's blood cancer drug
The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and ...
FDA authorizes the first AI-driven MRI solution for safer Alzheimer's treatment
"Amyloid-lowering treatments represent an important advance in the treatment of Alzheimer's disease but they are associated ...
MedPage Today17h
FDA Approves First Menin Inhibitor for Acute Leukemia
The FDA granted full approval to the menin inhibitor revumenib (Revuforj) for adults and children 1 year and older with relapsed/refractory acute leukemia and a lysine methyltransferase 2A gene ( ...
FiercePharma2d
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...
pharmaphorum21d
FDA staffers defend Aduhelm approval in JAMA editorial
"When the FDA approves a drug under accelerated approval ... the effect on beta amyloid was either nil or smaller than seen in the aducanumab programme. They also reject suggestions that the ...
Pharmabiz6h
icometrix’s AI-driven MRI solution, icobrain aria receives US FDA clearance for safer Alzheimer’s treatment
AI-driven MRI solution, icobrain aria receives US FDA clearance for safer Alzheimer’s treatment: Boston Saturday, November 16, 2024, 16:00 Hrs [IST] icometrix, a g ...
Cure Today18h
FDA Approves Revuforj for Relapsed/Refractory Acute Leukemia Subset
Revuforj was approved by the FDA for adults and children with relapsed/refractory acute leukemia with a KMT2A translocation.
The American Journal of Managed Care13d
Contributor: The Era of Disease-Modifying Alzheimer Disease Treatments
New treatments for Alzheimer disease don’t reverse cognitive symptoms, but they do significantly slow progression. Evidence suggests that earlier treatment is most effective.
FDA Approves PTC's Kebilidi As First Gene Therapy To Treat AADC Deficiency
The U.S. Food and Drug Administration approved PTC Therapeutics, Inc.'s Kebilidi (eladocagene exuparvovec-tneq) gene therapy for the ...
Yahoo Finance29d
FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment
The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...