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Death rates for metastatic cancers have dropped by 5 to 6 percent annually for elderly patients the past three years, in part because of two “game-changing drugs” approved almost a decade ago by the FDA, according to the American Cancer Society (ACS). Read More
For the second year in a row Novartis has been named the most innovative pharma company in the industry by the Innovation Index, a collaboration between CNS Summit and IDEA Pharma. Read More
The agency aims to develop “a robust infrastructure, cloud-forward plans, clear and efficient external data interfaces, and a focus on cybersecurity.” Read More
The FDA released a new plan on Wednesday for using data to help bridge the “persistent gap” between scientific innovations and the technology needed to develop them into therapies. Read More
Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Read More
Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Read More
The guidance points out that conventional pharmacokinetic studies that use intensive blood sampling can rarely be used in neonate studies due to their limited circulating blood volume. Read More
Researchers should use innovative approaches and all information available when designing a neonatal study, as neonates come with serious considerations, such as a limited amount of circulating blood and rapid and varying rates of maturation, the agency advises in draft guidance. Read More
The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug applications. Read More
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