Once the CDC accepts the recommendation of its Advisory Committee on Immunization Practices (ACIP), the COVID-19 vaccine regimen, at least for the Pfizer Inc.-Biontech SE vaccine, will include a booster dose for everyone 12 and older. ACIP voted 13-1 at a Jan. 5 emergency meeting to recommend the booster dose for 12- to 17-year-olds at least five months after a primary series of the Pfizer vaccine.

Over the course of the past two years, two presidential administrations and the U.S. Congress have set considerable sums of money aside for testing for the COVID-19 pandemic, but reports of shortages of tests have prompted a response from Capitol Hill.

Researchers at the University of Pennsylvania’s Perelman School of Medicine have shown how nanoparticles could be used to reduce neutrophil clumping in inflamed lungs – making them a pathway for diagnosis and treatment of acute lung inflammation (ALI) and acute respiratory distress syndrome (ARDS).

A split decision from the U.S. Court of Appeals for the Federal Circuit could give Novartis AG’s blockbuster multiple sclerosis drug, Gilenya (fingolimod), a little more breathing room from unlicensed generics.

After a six-month long trial, a jury found Teva Pharmaceuticals USA Inc., a subsidiary of Jerusalem-based Teva Pharmaceutical Industries Ltd., liable in contributing to New York state’s opioid crisis that saw thousands die.

In the season of college bowl games, two long-time rivals are vying for another title, the right to claim being the first to install Siemens Healthineers AG’s Magnetom Free.Max magnetic resonance imaging (MRI) system. Both the Ohio State University and the University of Michigan said they were first in the U.S. to put in the recently approved system.

Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier.

Genetic testing for health care purposes took a hit with the onset of the COVID-19 pandemic, but there are concerns about the volume of these tests in the four years before the onset of the pandemic. The U.S. Office of Inspector General (OIG) said recently that the data suggest possible fraud and abuse of the Medicare program, and that the picture suggests a need for a more concerted regulatory effort by the CMS.

The run on at-home COVID-19 tests may be for naught. The FDA warned that the popular rapid antigen tests recommended to keep New Year’s Eve revelers, relatives visiting elderly grandparents and workers exposed to the coronavirus from spreading COVID-19 are less likely to detect the Omicron variant than earlier strains of the virus. “Early data suggest that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said in an update on Dec. 29. Despite the higher rate of false negatives, the FDA said individuals should continue to use the tests. Those experiencing symptoms or with a high likelihood of infection based on exposure should follow-up with a molecular test if their antigen test returns a negative result.