FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies). Qfitlia does not replace a clotting factor. It is a new type of drug that works by reducing the amount of a protein called antithrombin. This increases the amount of thrombin, an enzyme that is critical for blood clotting. The prescribing information for Qfitlia includes a boxed warning about thrombotic events and acute and recurrent gallbladder disease. It also has a warning and precaution about liver toxicity. The most common side effects of Qfitlia are viral infection, common cold symptoms (nasopharyngitis), and bacterial infection. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/eyzpbdEY
About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
- Website
-
http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
-
Primary
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
-
FDA approves durvalumab with gemcitabine and cisplatin chemotherapy for adults with muscle invasive bladder cancer. https://lnkd.in/g35T9VqS The most common adverse reactions in more than 20 percent of clinical trial participants who used this combination were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphate, rash, diarrhea, pyrexia, and abdominal pain. Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq
-
-
FDA expanded the indication for Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy. https://lnkd.in/eSrV5Nii Adverse reactions were consistent with prior experience with lutetium Lu 177 vipivotide tetraxetan. Treatment with lutetium Lu 177 vipivotide tetraxetan may result in risk from radiation exposure, myelosuppression, and renal toxicity. Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq
-
-
NEW DATE: The FDA has rescheduled the webinar on the Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” to April 10, 2025, at 1pm EDT. (If you have already registered for the previously scheduled webinar, you do NOT need to sign-up again.) This webinar will provide an overview of the recently released final rule to update the definition of the nutrient content claim “healthy” that manufacturers can voluntarily use on food packages. The updated “healthy” claim provides a quick signal on food package labels to help consumers identify foods that can be the foundation of healthy eating patterns. This action is part of the FDA’s broader commitment to make food a vehicle for health and wellness, reduce diet-related chronic diseases, and promote health equity. https://lnkd.in/dWktm7hh
-
-
📢 Now Available! The CDER ARC Program’s LEADER 3D initiative published 2 new videos that provide an overview of important considerations for selecting endpoints when designing clinical trials, and concepts to consider when determining how to leverage natural history study data in rare disease drug development programs. The LEADER 3D educational resources were developed based on the needs and priorities we heard from our valuable partners in the rare disease drug development community. Learn more & watch videos: ➡️ https://lnkd.in/dN3Eqw4B
-
-
The FDA updated the Problems Reported with Essure web page to include information on the medical device reports received by the FDA related to Essure in 2024. Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA remains committed to collecting and providing updates on the long-term safety information about this device. https://lnkd.in/eUkzeHVk
-
-
Today the FDA published a new searchable FAQs page about the Guidance on Food Allergen Labeling (Edition 5), January 7, 2025. The guidance helps the food industry meet the requirements for listing the 9 major food allergens (milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame) on the labels of FDA-regulated foods. AND it helps consumers avoid ingredients they may be allergic to. https://lnkd.in/ebgkx4RZ
-
Consumers are increasingly using pulse oximeters in-home when they are not feeling well, or to monitor their general health. The FDA wants to help you breathe easy and know how these devices can be used safely and accurately. https://lnkd.in/esf5-Vju
-
🎉 FDA is celebrating 15 years of the Biologics Price Competition and Innovation Act (BPCIA)! In the latest CDER Conversation, Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars (OTBB), discusses how the BPCIA has impacted public health, biologics manufacturing, and the future of biosimilars ➡️ https://lnkd.in/emxgTmGY
-
-
FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET. https://lnkd.in/edhraW9j The safety profile for cabozantinib was consistent with the approved product label. Learn more in the FDA-approved prescribing information to be posted at: https://lnkd.in/emUfeBq
-