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German drugmaker Merck KGaA and Pfizer have received breakthrough therapy designation for immunotherapy avelumab for second-line treatment of metastatic Merkel cell carcinoma. Read More
Roche subsidiary Genentech will exercise its option to commercialize Ophthotech’s wet age-related macular degeneration drug Fovista with Novartis outside the U.S. Read More
Heritage Pharmaceuticals has been hit with a warning letter for what the FDA calls “serious violations” of postmarket reporting requirements. 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