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A federal appeals court has rejected Jazz Pharmaceuticals’ attempt to overturn a lower court ruling invalidating a patent claim covering the company’s Risk Evaluation and Mitigation Strategies (REMS) distribution system for its blockbuster narcolepsy therapy Xyrem (oxybate). Read More
The FDA is bringing in ethicists to help the agency better frame issues around gene editing as well as data generation using patients with rare diseases that have no cure, said FDA Commissioner Robert Califf, speaking during the agency’s Rare Diseases Day 2023 virtual public meeting on Monday. Read More
Attorneys general from a dozen states have filed a lawsuit against the FDA over its Risk Evaluation and Mitigation Strategies (REMS) for the abortion pill, mifepristone, arguing that the restrictions are not necessary and create burdens for patients. Read More
The FDA will soon announce a new pilot program to help developers of gene therapies for rare diseases get their treatments approved faster, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), at the agency’s Rare Diseases Day 2023 virtual public meeting on Monday. Read More
The FDA should move more quickly to withdraw its approval of drugs granted Accelerated Approval (AA) when negative confirmatory trial data emerge, said members of a research team that studied cancer patients treated with AA drugs. Read More
The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. Read More
HHS has published a subset of its semiannual rulemaking agenda for 2023, outlining those planned rules – including several from the FDA – that are likely to have a significant economic impact for some small entities.