Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels.
The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.
The approval of Jakafi marks the first approved treatment for this indication in the United States.
The administration sees the push for transparency as a tool to help consumers control the costs of their health care.
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
ADL Bionatur Solutions recently reported Q119 results, showing positive €0.11m EBITDA, and over 134% year-on-year revenue growth to €10m, driven by 180% growth in contract manufacturing.
InflaRx reported financial and operating results for the first quarter ended March 31, 2019.
Medtronic plc announced financial results for its fiscal year and fourth quarter 2019, which ended April 26, 2019.
Singapore-based researchers have discovered a possible solution to impede the evolution of bacteria into superbugs that are resistant to drugs and therefore harder to kill.