COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks…

Since approval, the FDA has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with DDMD with ELEVIDYS, an adeno-associated virus vector-based gene therapy.

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.

For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Laboratory Information Bulletins available to the public

Information on general and specific vaccines

Sabores Fit Bakery of Kissimmee, FL is recalling MOUSSE DESSERTS, because they may contain undeclared Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts ( Almonds, Hazelnuts ). People…

Face Rock Creamery of Bandon, Oregon is voluntarily recalling two specific lots of its Vampire Slayer Garlic Cheddar Curds, 6oz. cups, Use By date 08292025, because it has the potential to be contaminated…

International Foodsource, LLC of Randolph NJ is recalling 10 oz packages of Southeastern Grocers Dark Chocolate Nonpareils, because it may contain undeclared milk. People who have an allergy or severe…