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- Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19Today, the FDA issued an emergency use authorization for two monoclonal antibodies to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19.
- What's New Related to DrugsWant to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
- Warning Letters 2020Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.
- FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid LaminopathiesToday, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford Progeria Syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older.
- Generic Drug Research Collaboration OpportunitiesThe Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.