Healthcare news
Breaking news, regulatory updates, FDA / EMA / WHO / national health ministry announcements.
- FDA
FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
- FDA
Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods
Omnipod Pods may not deliver insulin as intended due to a tear in the internal tubing.
- FDA
FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
FDA announces results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market.
- FDA
FDA Announces Major Steps to Implement Real-Time Clinical Trials
The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT).
- FDA
FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
On April 18, President Trump issued an Executive Order directing the U.S. Department of Health and Human Services (HHS) to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions.
- FDA
FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy.
- FDA
CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
CMS and FDA announce the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare.
- FDA
FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
Since publishing roadmap last April, agency has successfully launched several key initiatives to replace animal testing with better alternatives
- FDA
FDA Takes Step Forward on Testosterone Therapy for Men
FDA is taking an initial step to advance treatment options for men’s health by encouraging sponsors of approved testosterone replacement therapy products to contact FDA for information if they are interested in pursuing a potential new indication for low libido in men with idiopathic hypogonadism.
- FDA
FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
The U.S. Food and Drug Administration today issued a draft guidance for sponsors seeking approval of human gene therapy products involving genome editing technologies.