FDA Commissioner Scott Gottlieb, MD, announced the agency’s progress in streamlining the orphan drug review process and outlined plans to close a loophole currently hindering pediatric drug research.
It's also true, Rao explained, that some of the drugs that go through the orphan process may not specifically treat a rare disease. For example, a very toxic cancer drug might may not work well in ...
The U.S. Food and Drug Administration's process for reviewing drugs that aim to treat rare diseases lacks thorough documentation that could prevent a life-saving antidote from getting to market, ...
But lucrative financial incentives created by the Orphan Drug Act signed into law by President Ronald Reagan in 1983 succeeded far beyond anyone’s expectations. More than 200 companies have brought ...
TORONTO and HAIFA, Israel, Feb. 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (NRX:CA) (FSE: J90) (NRX.V), known as "NurExone," is pleased to announce the initiation of the Orphan Drug ...
More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored. By the ...
More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored. By the ...
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