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An FDA advisory committee on Wednesday approved the risk-benefit profile of Amgen’s romosozumab, a monoclonal antibody for treatment of osteoporosis. Read More
As the partial government shutdown grinds on, the FDA resumed issuing guidance on Wednesday with a revised draft guidance to help sponsors of rare disease treatments conduct more effective clinical trials. Read More
The FDA released draft guidance Wednesday for companies seeking amendments or final approval for tentatively approved ANDAs — the first guidance to emerge during the partial government shutdown. Read More
The new office will use tools such as biomarkers, biomedical informatics and real-world evidence as more integral components of the drug review process. Read More
Sentinel is “a critical engine for methodological innovation and a platform to advance the science of real world evidence,” Commissioner Gottlieb said. Read More
The American Hospital Association urged the FDA to seek authority from Congress to require more stringent disclosures by drugmakers to help limit prescription drug shortages. Read More
Drugmakers are pushing back against claims by newly-seated House Oversight Committee Chair Elijah Cummings (D-Md.) about their drug pricing practices, but say they will cooperate with the committee’s investigation. Read More
In anticipation of a surge of investigational new drug applications for cell and gene therapies in the next few years, FDA Commissioner Scott Gottlieb and CBER Director Peter Marks on Tuesday announced plans to issue new guidance to advance their development. Read More