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The FDA is reaching out to states that have filed applications with the agency seeking approval to directly import prescription medicines from Canada. Read More
Alzheimer’s disease drug Aduhelm and other investigational anti-amyloid antibodies similar to Aduhelm will only be covered by Medicare and Medicaid if they’re used in the setting of a federally approved study, the Centers for Medicare and Medicaid Services (CMS) announced yesterday. Read More
Generics and biosimilars will slow the overall pace of drug spending growth this year, even though U.S. prescription drug spending is slated to rise by 4 to 6 percent year-over-year in 2022. Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a Stronger FDA. Read More
Repeated COVID-19 boosters simply aren’t a practical way to deal with the shape-shifting SARS-CoV-2 virus, according to members of the FDA’s Vaccines and Related Biologics Advisory Committee. Read More
Two draft guidelines from the International Council for Harmonization (ICH) were released yesterday for public comment, one on pediatric extrapolation in clinical trials and the other on calculating compound-specific acceptable intakes. Read More
The FDA issued a final guidance yesterday for sponsors of drugs and biologics for the treatment of chronic hepatitis B that expands upon a November 2018 draft. Read More
The FDA has withdrawn its Emergency Use Authorization (EUA) for the GlaxoSmithKline and Vir Biotechnology COVID-19 monoclonal antibody treatment sotrovimab based on data indicating that it isn’t effective against the Omicron BA.2 subvariant. Read More
In one of his first public presentations as FDA commissioner, Robert Califf outlined his vision for enhanced use of health data as the way to improve health outcomes. Read More