The warning label placed on all estrogen-based treatments since 2003 was based on an outdated and flawed government-funded study.
The U.S. Food and Drug Administration's (FDA) chief says the agency will begin offering bonuses to drug reviewers who ...
March 2 (Reuters) - Intellia Therapeutics said on Monday the U.S. Food and Drug Administration has removed a clinical hold on ...
BioMarin’s Voxzogo (vosoritide) won FDA approval in paediatric achondroplasia in November 2021 and secured a label extension ...
The FDA has liberated the second of two Intellia Therapeutics clinical trials that were put on hold last October following a report of serious liver toxicity that later led to death.
Pfizer CEO Albert Bourla said the company "has a problem" with the U.S. Food and Drug Administration's biologics and vaccines chief, Vinay Prasad.
UniQure said Monday that plans to seek approval for its Huntington’s disease treatment with the Food and Drug Administration ...
The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete ...
Ascendis Pharma is spiraling upward by way of its TransCon platform. | Ascendis Pharma is spiraling upward by way of its TransCon platform. For the third time in six years, the Copenhagen-based ...
Shares of uniQure plummeted more than 40% in premarket trading Monday after the company confirmed the FDA has rejected its current data package for AMT-130, a highly anticipated gene therapy for ...
4don MSN
FDA Commissioner Dr. Makary on rare disease therapy approvals, internal politics at the agency
FDA Commissioner Dr. Marty Makary joins 'Squawk Box' to discuss the agency's efforts to accelerate the development of ...
Her son Ben, she learned, had mucopolysaccharidosis (MPS) type 2, or Hunter Syndrome, one of a group of rare diseases that is ...
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