The U.S. FDA, Health Canada, and the U.K. Medicines and Healthcare Products Regulatory Agency have once again sidestepped the usual mechanisms for international regulatory cooperation to strike a blow for harmonization.
Seastar Medical Holding Corp. was granted a third breakthrough device designation by the U.S. FDA for its Selective Cytopheretic device (SCD), a biomimetic membrane-based device used to treat patients with acute inflammatory conditions, which can cause organ failure and death. The latest designation is for its use in patients with hepatorenal syndrome. It follows other indications including cardiorenal syndrome and in adults with acute kidney injury (AKI).
With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond those already established on the country’s two coasts, the Biden administration designated 31 communities, out of more than 370 applicants, as Regional Innovation and Technology Hubs.
The U.S. FDA is once again revising its guidance on how drug and device makers can share scientific reprints and reference texts with health care providers regarding off-label uses of their approved or cleared products.
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.
Pfizer Inc. entered into a conciliation agreement with the U.S. Department of Labor’s Office of Federal Contract Compliance Programs to resolve alleged compensation discrimination affecting female employees at its New York headquarters.
As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.”
Wandercraft SAS has begun commercial operations of its exoskeleton, Atalante X, in the U.S., offering another solution to the millions of people living with mobility impairments. The company also formed a partnership with the Kessler Foundation whose research team will investigate the possible benefits of the Atalante X for neurologically impaired patients, including those recovering from stroke, spinal cord injuries and motor neuron disease.
A week before the U.S. Senate Health, Education, Labor and Pensions Committee is scheduled to vote on the confirmation of Monica Bertagnolli as the next NIH director, she faced a grilling by the committee fueled by drug pricing agendas and deals the Biden administration made with certain lawmakers to advance her nomination.
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
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