News
Biden seeks to return Califf as FDA chief
President Joe Biden said on Nov. 12 that he’ll nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration once again...
News
FDA stands firm on deadline for clozapine REMS recertification
Prescribers and pharmacies who fail to be certified by Nov. 15 will no longer be able to prescribe/dispense the drug.
News
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.
News
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.
News
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.”
News
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.
News
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.
News
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...
News
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.
News
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...
News
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.
News
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...
News
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.