FDA approved two new drugs for rare diseases this week!
Learn more about these approvals and other good news:
Petroleum-based food dyes add color but no nutritional value.
That’s why the FDA is tracking industry pledges to remove petroleum-based food dyes.
Check out where companies stand ➡️ https://www.fda.gov/food/color-additives-information-consumers/tracking-food-industry-pledges-remove-petroleum-based-food-dyes
#NationalNutritionMonth
For patients with severe Leukocyte Adhesion Deficiency Type I (LAD-I), treatment options have been limited. A new gene therapy may offer hope through the FDA’s accelerated approval pathway. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-severe-leukocyte-adhesion-deficiency-type-i
R to @US_FDA: Avlayah received breakthrough therapy, fast track, priority review, and orphan drug designations. Families with young children with Hunter syndrome will now have access to a product that may favorably alter the course of the disease at the crucial time in life when there is the greatest potential for benefit.
Marking a milestone for children and their families battling Hunter syndrome, the FDA has approved the first ever product to address neurologic complications of this very rare and often severe disorder. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-neurologic-manifestations-hunter-syndrome
FDA’s new guidance on Bayesian statistics is creating a lot of buzz!
“The importance of the guidance cannot be overstated. It underscores FDA’s commitment to modernizing clinical research and promoting the use of bayesian methods in clinical trials.”
https://jamanetwork.com/journals/jama/fullarticle/2847011
Choosing lower-sodium foods supports heart ❤️ health and helps manage blood pressure.
Check the Nutrition Facts label next time you shop 🛍️🛒 https://www.fda.gov/food/nutrition-education-resources-materials/sodium-your-diet
#NationalNutritionMonth
#EatInformed
Yesterday, @HHSGov recognized @WorldDSDay by celebrating the lives and resilience of people with Down syndrome. @SecKennedy and @DrMakaryFDA spent meaningful time with local families, underscoring the power of community and our commitment to supporting people with disabilities at every stage of life.
We’re delivering for cancer patients who have been waiting for game-changing therapies.
Another busy week at FDA!
Are you ready to shape the future of public health at the highest levels?
The FDA is seeking an exceptional executive leader to serve as the Center Director for CBER—a role at the forefront of regulating life-saving biological products, vaccines, and emerging therapies.
This is an opportunity to protect and advance public health on a national scale. You'll work on cutting-edge science, shape critical regulatory policy, and lead a team dedicated to ensuring the safety and effectiveness of biological products that save lives.
Apply by April 3, 2026. #FDAJobs
https://www.usajobs.gov/job/862056100?_gl=1*70um01*_ga*NjY5MTU1MjI3LjE3NTE0MDE3OTQ.*_ga_5222X8D281*czE3NzQwMzY0NTkkbzUkZzEkdDE3NzQwMzgyNzAkajU2JGwwJGgw
As you enjoy more real foods under the new Dietary Guidelines for Americans, don’t forget to practice food safety.
Follow these steps when cleaning fruits 🍊 🍎 and vegetables 🥕 🥦 to reduce dirt and bacteria. https://www.fda.gov/consumers/consumer-updates/7-tips-cleaning-fruits-vegetables#:~:text=If%20possible%2C%20FDA,below%2040%20degrees
#NationalNutritionMonth #EatRealFoodSafely
If a drug is already widely used in humans abroad, the FDA shouldn’t require routine testing in animals.
The FDA seeks public input on the Commissioner's National Priority Voucher program—an ultra-fast review pathway for drugs of strategic national importance.
The agency has awarded vouchers for 18 products and granted four approvals, including two oncology drug approvals that were delivered in less than 60 days.
Join us on June 12 for a public hearing.
https://www.fda.gov/news-events/press-announcements/fda-schedules-public-meeting-commissioners-national-priority-voucher-pilot-program
Another impressive result for the national priority voucher program. 54 days for a full FDA review! 🇺🇸
FDA approves Wegovy HD, a higher-dose Wegovy (7.2 mg semaglutide), in just 54 days—marking the 4th success under @DrMakaryFDA's National Priority Voucher pilot program.
Learn more about how FDA is accelerating access to innovative treatments: https://www.fda.gov/news-events/press-announcements/fda-approves-fourth-product-under-national-priority-voucher-program-higher-dose-semaglutide
FDA announces an April 23 public meeting and comment period - "Increasing Access to Nonprescription Drugs".
Join the conversation on expanding safe, effective nonprescription drug access. Discussion on industry challenges, scientific opportunities & collaboration.
Learn more: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-increasing-access-nonprescription-drugs-04232026
Some FDA decisions are taking WEEKS.
Thank you to the dedicated FDA scientists who are making this unprecedented efficiency possible.
Today: another action to stop unnecessary animal testing. We can do better.
🎉🥗 This #NationalNutritionMonth, we’re celebrating 120 years of the FDA helping protect and promote public health. 🎂🎊
From food safety to nutrition information, FDA supports informed choices so families can feel confident about what’s on their plates today and every day.
#FDA120
#EatInformed
#EatRealFoodSafely
Fewer animals. Better data. Faster cures.
Today’s draft guidance on New Approach Methodologies (NAMs) accelerates the shift to human-centric science—advancing ethical, more predictive, and faster drug development. https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-alternatives-animal-testing-drug-development
I never imagined 5,000 gathering to talk about medical quality. As @DrOzCMS says, the most expensive part of health care is poor quality care.
We must go big when it comes to biotech regulatory reform—unapologetically America First. Thank you @DrOzCMS for hosting @NIHDirector_Jay & I in Baltimore.
Learn how @US_FDA’s Office of Coordinated Outbreak Response, Evaluation & Emergency Preparedness works to find, stop, and help prevent foodborne illness outbreaks in foods like carrots, cheese, chocolate and many others in their annual report. https://www.fda.gov/food/hfp-constituent-updates/fda-releases-core-2024-annual-report-investigations-foodborne-outbreaks-and-adverse-events-fda
Pro tip: FDA-approved spirulina extract can be a great natural alternative to artificial petroleum-based green dyes.
FDA is setting new records in how rapid we are approving cancer drugs—some are so powerful, they have the potential to bring patients out of hospice.
Kids don’t need to tip-toe around healthy fats in food.
FDA is tracking industry pledges to remove petroleum-based food dyes to help support healthier food options, especially for kids.
Learn more about the agency’s role in this effort. https://www.fda.gov/food/color-additives-information-consumers/tracking-food-industry-pledges-remove-petroleum-based-food-dyes
#NationalNutritionMonth #EatInformed
Colorectal cancer impacts women too. Screening may save your life.
@US_FDA provides information about the different screening options available to you. Learn more: https://www.fda.gov/consumers/consumer-updates/colorectal-cancer-what-you-should-know-about-screening
More affordable versions of biologic drugs are on the way.
The FDA is moving at LIGHT SPEED ⚡️🇺🇸
✅ Cutting red tape on BIOSIMILARS to lower costs for your family
✅ MAHA Mission for supplement safety
✅ STOPPING the Screwworm parasite
✅ 1K+ NEW JOBS for top scientists
✅ Launching AEMS to modernize safety and save taxpayer dollars
FDA testing shows that 8 lots of Quest Cat Food contain extremely low or no thiamine (vitamin B1), an essential vitamin for cats. Continued feeding of the products could result in thiamine deficiency and cause serious health issues, including death.
If your cat has eaten the products and is showing symptoms such as vomiting, loss of appetite, muscle weakness, wobbly gait, falling, or seizures, stop feeding the products and contact a veterinarian immediately. If left untreated, thiamine deficiency can be deadly. https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-advisory-certain-lots-quest-cat-food-pose-serious-health-risks-due-extremely-low-levels-thiamine
Are you getting your 3 servings of dairy daily 🥛🧀?
Check the Nutrition Facts label for protein, calcium, vitamin D, added sugars & saturated fat: https://www.fda.gov/food/nutrition-education-resources-materials/using-nutrition-facts-label-choose-milk-and-plant-based-beverages
#NationalNutritionMonth #EatInformed
The U.S.-Mexico papaya partnership offers a blueprint for global food safety. By combining regulatory expertise with industry commitment, we've gone from multiple Salmonella outbreaks (2011-2019) to zero outbreaks since 2020—a major public health win!
https://www.fda.gov/food/international-cooperation-food-safety/improving-safety-imported-papayas
Today, FDA issued final guidance for medical devices with indications for use associated with weight loss as part of the FDA’s ongoing efforts to support the development of safe and effective medical devices that can improve health outcomes and reduce the burden of chronic disease in the U.S. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-devices-indications-associated-weight-loss-premarket-considerations?utm_medium=email&utm_source=govdelivery
Productive meetings in Mexico City this week with @Agricultura_mex, @SENASICA, @COFEPRIS, and our @US_FDA Office of Latin America team. Discussed critical food safety priorities including Cyclospora prevention, agricultural water safety, and traceability for fresh produce. Ongoing partnership and collaboration are key to protecting public health across our borders and for ensuring safe, fresh produce for American families. #MAHA #foodsafety
The FDA is transforming how we monitor product safety. Beginning today, the new Adverse Event Monitoring System (AEMS) replaces a patchwork of costly databases with one unified, real-time platform.
This infrastructure overhaul will reduce costs by $120M over five years, while providing real-time public access to critical safety data. https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool
Cutting back on added sugars?
Check the Nutrition Facts label to compare foods and choose foods lower in added sugars. https://www.fda.gov/food/nutrition-facts-label/added-sugars-nutrition-facts-label
#NationalNutritionMonth #EatInformed
Reflecting the FDA's commitment to accelerating cures and expanding treatment options for patients with serious and unmet needs, the agency approved expanded use of Wellcovorin (leucovorin calcium) tablets to treat cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1).
Leucovorin is the first treatment for this rare genetic condition. Learn more: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-cerebral-folate-transport-deficiency
Today the FDA cut unnecessary red tape on biosimilar medications (which are the “generic” versions of expensive biologic drugs).
Lower R&D costs ➡️ lower drug prices for Americans.