FDA authorizes additional Moderna, J&J shots, broadening booster rollout

The agency also cleared booster shots of all three currently available vaccines to be used interchangeably, a so-called mix-and-match approach that recent study results showed could boost immune responses.

By Shoshana Dubnow • Oct. 21, 2021

Biden administration rolls out plan for vaccinating children as FDA weighs clearance

The plan is dependent on FDA authorization and CDC recommendation of Pfizer's vaccine for children aged 5 to 11 by early next month.

By Shoshana Dubnow • Oct. 20, 2021

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Surprise Billing

Federal legislation banning surprise bills has hit a barrage of roadblocks, complicating efforts to protect consumers from unexpected out-of-network charges.

By Healthcare Dive staff

Over-the-counter hearing aids proposed by FDA

The policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by a few companies, a Cowen analyst said.

By Greg Slabodkin • Oct. 19, 2021

Anatomy of a medical device recall: How defective products can slip through an outdated system

A fragmented system has medtechs notifying hospitals via mail or FedEx, leading to missed notices, putting patients at risk, critics say.

By Ricky Zipp • Oct. 19, 2021

Zelis helps address new NSA and TiC regulations

Learn more about innovative solutions that can help you comply with new regulations.

Oct. 18, 2021

FDA panel endorses second shot for adults who received J&J vaccine

Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

By Ben Fidler • Oct. 15, 2021

Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload." 

By Greg Slabodkin • Oct. 15, 2021

Biden circling former FDA chief Califf to again lead agency: report

The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.

By Ricky Zipp • Oct. 15, 2021

FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting

Advisers are discussing an authorization of Moderna's booster on Thursday, with a vote on recommendations to the FDA expected this afternoon.

By Shoshana Dubnow • Oct. 14, 2021

FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.

By Nick Paul Taylor • Oct. 13, 2021

AstraZeneca builds case for long-acting COVID-19 drug, but is it too late?

The British drugmaker could soon become the first with both a marketed vaccine and treatment for COVID-19, a notable achievement. Yet competition has blunted the potential impact of each of them.

By Ben Fidler • Oct. 12, 2021

Medicare Advantage, Part D plans with 4 or more stars soaring, CMS says

About 90% of people currently enrolled in MA plans offering prescription drug coverage are enrolled in a plan that will earn four stars in 2022.

By Hailey Mensik • Oct. 11, 2021

Merck, Ridgeback seek US clearance of first oral COVID-19 drug

The two partners have officially filed for emergency authorization of their antiviral pill, a milestone in the fight against COVID-19. It's not yet clear whether vaccine recipients will be eligible for treatment, however.

By Ben Fidler • Oct. 11, 2021

The 21st Century Cures Act update: where we've been and where we're going

Learn what's changed and how you can leverage technology and data to shape the healthcare of tomorrow.

Oct. 11, 2021

Will a software bill of materials help or hurt medical device cybersecurity?

For years, FDA has talked about the need for an electronically readable inventory of third-party components in devices, as a way to address the problem of widespread cyber vulnerabilities.

By Greg Slabodkin • Oct. 8, 2021

Pfizer officially seeks FDA clearance for coronavirus vaccine in children

The companies' application starts a pressure-packed FDA review that could open up COVID-19 shots for tens of million Americans between the ages of 5 and 11.

By Shoshana Dubnow • Oct. 7, 2021

Feds OK health plan discounts for coronavirus vaccination

Such rewards must meet certain requirements, however, including a rule that they not exceed 30% of the cost of employee-only coverage.

By Kate Tornone • Oct. 7, 2021

Hospital M&A in 2021 characterized by fewer but much larger deals

Hospitals are increasingly looking outside traditional care delivery methods threatened by COVID-19 to diversify business models by pursuing stakes in home health, virtual care and post-acute services.

By Shannon Muchmore • Oct. 7, 2021

J&J asks FDA to clear booster dose of its coronavirus vaccine

The agency is holding an advisory committee meeting on Oct. 15 to discuss a second dose of J&J's shot, as well as boosting with different vaccines.

By Ned Pagliarulo • Oct. 6, 2021

Collins to step down as NIH head in transition for research agency

After 12 years in the top job, the veteran director says a new scientist should assume leadership of the world's largest biomedical research institution.

By Jonathan Gardner • Oct. 5, 2021

Air ambulance charges zoom upward for commercial insurers, but not Medicare

Allowed in-network charges for fixed-wing air ambulances rose 76.4% between 2017 and 2020, and now top $15,000, a new study by Fair Health found.

By Ron Shinkman • Oct. 4, 2021

MA premiums will dip as payers expand footprints

Cigna, UnitedHealth and Centene are all entering new areas for 2022, but analysts say benefit options show that bids from insurers are relatively conservative.

By Shannon Muchmore • Updated Oct. 5, 2021

Centene reaches $72M settlement with Illinois, Arkansas for alleged Medicaid overcharges

The two states allege Centene failed to disclose relevant discounts and inflated dispensing fees. The latest settlements come months after similar agreements were reached in Ohio and Mississippi.

By Samantha Liss • Oct. 1, 2021

Doctors slam surprise billing rule that details dispute resolution process

The interim final rule established that existing rates in a provider's geographic area will be a strong anchor for final payment decisions by arbitrators.

By Shannon Muchmore • Oct. 1, 2021

Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug

The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible."

By Ben Fidler • Oct. 1, 2021