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Despite agreeing that Telesta’s bladder cancer biologic candidate would offer limited side effects and low toxicity — maybe even less than standard of care — FDA reviewers voted against recommending it Wednesday because of a lack of proven benefit. Read More
Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More
During clinical development, biosimilars makers can request as many meetings with FDA reviewers as necessary but they need to be outcomes-based with a priority on narrowly defined questions that the FDA can answer. Read More
The Department of Justice, the FDA and other federal partners announced a nationwide sweep that resulted in the filing of criminal and civil cases against 89 makers of dietary supplements. Read More
The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, supported Robert Califf’s nomination as the next FDA commissioner Tuesday. Read More