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FDA posts new websites on accelerated approvals for cancer drugs
The controversial approval of aducanumab for Alzheimer’s disease drew more attention to a cancer debate already underway.
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FDA approves avacopan for rare ANCA autoimmune disease
ChemoCentryx said it plans to price its new medicine at an annual cost of $150,000-$200,000 for U.S. patients.
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Zero benefit of aducanumab for Alzheimer’s disease, expert panel rules
“If I had to guess, I think the data is stronger for net harm than it is for that benefit.”
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Contentious Alzheimer’s drug likely to get national coverage plan, CMS says
It will accept public comments about how Medicare should cover aducanumab through Aug. 11.
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Medicare proposes direct payments to PAs, telehealth expansion
Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements.
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NIAID advances universal flu vaccine candidate into phase 1 trial
“It could be longer lasting than the traditional flu vaccine and give us what we call super seasonal protection that might go beyond just one flu...
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More and more doctors abandoning private practice
This is the first time private practice was not the dominant approach since the AMA analysis began in 2012.
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Bill seeks to streamline prior authorization in Medicare Advantage plans
A House bill would compel insurers to streamline processes for prior authorization decisions for Medicare Advantage plans, seeking a shift to...
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CDC recommends use of Pfizer’s COVID vaccine in 12- to 15-year-olds
ACIP voted 14-0 in favor of the safety and effectiveness of the vaccine in younger teens.
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FDA panel narrowly backs avacopan approval
The FDA is mulling whether to approve avacopan for ANCA-associated vasculitis based largely on a single trial about which the agency staff has...
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FDA panel votes against 2 cancer indications but backs 4 of 6
At a 3-day meeting, an FDA advisory group considered the accelerated approvals of six cancer indications for three immunotherapies.
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FDA panel backs atezolizumab for mTNBC – at least for now
FDA advisers voted to keep in place an approval for atezolizumab in metastatic triple-negative breast cancer.