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The therapy, branded Beyfortus, was approved for preventing lower respiratory tract disease in infants born during or entering their first RSV season, and in children up to 24 months of age who ...
U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year.
It requires the FDA to submit an annual report to congressional committees that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved ...
The competition is presented by the Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded through the Food and Drug Administration (FDA), and Additional Ventures, a nonprofit focused on accelerating research progress and improving clinical care for individuals born with single ...
Infants should get a recently approved drug to protect them against a respiratory virus that sends tens of thousands of American children to the hospital each year, U.S. health officials said ...
Rank Brand Name(s) Generic Name Sales Q1 2014 Sales ($000) Change from Q4 2013 Company(ies) Disease/Medical Use First Approval Date Patent Expiration Date [6] [7]; 1: Abilify
Sketch of a Dalkon Shield IUD. The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A.H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of women, which eventually led to numerous lawsuits, in which juries awarded millions of dollars in compensatory and punitive damages.
WASHINGTON, Aug. 21, 2024 (GLOBE NEWSWIRE) -- The Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded by the Food and Drug Administration (FDA), announces today it is partnering with Additional Ventures, a nonprofit foundation focused on accelerating research progress and improving clinical care for individuals born with ...
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