Category: fda

Alzheimer’s Drug Targets People With Mild Cognitive Impairment. What Does That Mean?

The condition can be an early signal of Alzheimer’s disease, but not always. Other health concerns could be causing thinking or memory problems, and the new drug, Aduhelm, would not be appropriate for those patients.

Who Qualifies for a Covid Booster? The List Is Growing Longer

KHN’s Sarah Jane Tribble and Arthur Allen join Science Friday host Ira Flatow to recap the evolving news in the run-up to offering booster shots for the covid vaccine.

KHN’s ‘What the Health?’: The Autumn of Democrats’ Discontent

Congress is back in session with a short time to finish a long to-do list, including keeping the government operating and paying its bills. Hanging in the balance is President Joe Biden’s entire domestic agenda, including major changes proposed for Medicare, Medicaid and the Affordable Care Act. Meanwhile, the new Texas abortion law that bans the procedure early in pregnancy is prompting action in Washington. Joanne Kenen of Politico, Mary Ellen McIntire of CQ Roll Call and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Also, Rovner interviews former FDA Commissioner Scott Gottlieb about his new book on the covid-19 pandemic.

Biosimilar Drugs Are Cheaper Than Biologics. Are They Similar Enough to Switch?

Biologic drugs, made from living organisms, and the cheaper biosimilar drugs that mimic them are more complex than chemical drugs and their generic counterparts. The Food and Drug Administration says biosimilars are as safe and effective as the biologics, and doctors agree — but they are cautious about changing the treatment regimen of patients doing well.

Public Health Experts ‘Flabbergasted’ That Biden Still Hasn’t Picked an FDA Chief

The Food and Drug Administration has been mired in controversies related to drug approvals and covid vaccines, all without a permanent leader.

How Fauci and the NIH Got Ahead of the FDA and CDC in Backing Boosters

With real-time data streaming in from highly specialized researchers in the U.S. and abroad, NIH scientists became convinced that boosting the covid-19 vaccine was needed to save lives, prompting the president to announce a plan with a Sept. 20 start date. Scientists at the regulatory agencies weren’t yet convinced. A meeting Friday will determine what happens next. Here’s the story from behind the scenes.

KHN’s ‘What the Health?’: Vaccine Approval Moves the Needle on Covid

The FDA’s formal approval of the first vaccine to prevent covid-19 may or may not prompt doubters to go out and get shots, but it has clearly prompted employers to make vaccination a work requirement. Meanwhile, moderates and liberals in the U.S. House put aside their differences long enough to keep a giant social-spending bill on track, at least for now. Joanne Kenen of Politico, Tami Luhby of CNN and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss these issues and more. Plus, for “extra credit,” the panelists suggest their favorite health policy stories of the week they think you should read, too.

Apple, Bose and Others Pump Up the Volume on Hearing Aid Options, Filling Void Left by FDA

A 2017 law designed to help lower the cost of hearing aids mandated that federal officials set rules for a new class of devices consumers could buy without needing to see an audiologist. But those regulations are still on hold.

Rush to Boosters Sparks Confusion, Differing Recommendations

With political pressure mounting to recommend boosters, what are the experts saying about how current vaccines work and the potential benefits of another dose?

‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors

In another twist on covid vaccine hesitancy, blood centers say they are starting to hear from transfusion patients demanding blood from unvaccinated donors. Experts say the option is neither practical nor medically justifiable.