WASHINGTON, D.C. — The Food and Drug Administration rolled out a rapid-fire series of moves this month that could reshape how Americans manage chronic disease, treat rare and life-threatening blood disorders, access new antibiotics, and even buy sunscreen and gonorrhea treatments—an unusually wide regulatory sweep that touched everything from home-based digital care to hospital transplant units.
On December 5th, the agency launched what it described as a first-of-its-kind digital health pilot, Technology-Enabled Meaningful Patient Outcomes, or TEMPO, aimed at expanding access to certain digital health devices while maintaining patient safety. The voluntary effort, developed by the FDA’s Center for Devices and Radiological Health, will test a risk-based enforcement approach for digital health tools intended to improve outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
FDA Commissioner Marty Makary said the pilot is designed to encourage technologies that “meet people where they are,” pointing to a model of care built around managing chronic disease outside traditional clinical settings. Under TEMPO, participating manufacturers would offer devices intended to provide care covered through the Centers for Medicare and Medicaid Services Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions model, while collecting and reporting real-world performance data. CMS Administrator Mehmet Oz said the partnership is intended to modernize care and expand access to technology-enabled, integrated services.
The pilot would allow participating manufacturers to seek FDA enforcement discretion for certain requirements, including premarket authorization and investigational device rules, while the FDA works with participants to define when that discretion is appropriate. The agency said devices could range from tools for low-acuity cardiometabolic conditions, such as prediabetes, to more complex cardiometabolic needs such as heart failure, as well as back strain and depression. The FDA said it will begin seeking statements of interest in January 2026 and expects to select up to about 10 manufacturers in each of four clinical use areas.
Then, in a separate announcement on December 8th, the FDA said it approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant therapy approved to treat patients with severe aplastic anemia, a rare disorder in which the bone marrow fails to produce enough blood cells and can be fatal. The therapy, previously indicated for certain blood cancers, is now approved for adults and pediatric patients ages 6 and older with severe aplastic anemia who lack a compatible donor after reduced-intensity conditioning.
FDA Center for Biologics Evaluation and Research Chief Medical and Scientific Officer Vinay Prasad called the approval “revolutionary,” saying earlier treatment has the potential to alter a patient’s life course. Omisirge is derived from donated umbilical cord blood stem cells that are chemically enhanced with nicotinamide and infused to restore blood and immune function. In a study cited by the FDA, 12 of 14 patients achieved early and sustained neutrophil engraftment, with a median time to neutrophil recovery of 11 days. The FDA said common side effects included febrile neutropenia, infections, hyperglycemia, immune thrombocytopenia, and pneumonia, and that autoimmune cytopenias occurred in 25% of patients. The approval was granted to Gamida Cell Ltd. and received Orphan Drug and Priority Review designations.
On December 9th, the FDA announced the first approval under its Commissioner’s National Priority Voucher pilot program, saying Augmentin XR (amoxicillin-clavulanate potassium) was approved in just two months through the accelerated pathway. The agency said the application supported national health priorities by strengthening domestic manufacturing capacity at a U.S. facility, a move positioned to help address antibiotic shortages tied to supply chain vulnerabilities and sudden demand spikes. The approval was granted to USAntibiotics.
That same day, the FDA also approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for Wiskott-Aldrich syndrome, a rare genetic disease that can cause bleeding, eczema, recurrent infections, and heightened risks of autoimmunity and malignancies. Waskyra is indicated for pediatric patients 6 months and older and adults with appropriate transplant eligibility when no suitable matched related donor is available. The FDA said evidence from two clinical studies and an expanded access program involving 27 patients showed substantial and sustained benefit, including a 93% reduction in severe infections in the months after treatment and a 60% reduction in moderate to severe bleeding events in the first year compared with the prior year. The FDA said common side effects included rash, respiratory infections, febrile neutropenia, catheter-related infection, gastrointestinal effects, liver injury, and petechiae. The approval went to Fondazione Telethon ETS, which the FDA said is the first approved cell and gene therapy product from a non-profit applicant.
On December 11th, the FDA proposed expanding the U.S. sunscreen ingredient list by adding bemotrizinol as a permitted active ingredient, citing data indicating broad UVA and UVB protection, low skin absorption, and rare irritation. If finalized, bemotrizinol could become an additional ingredient recognized as safe and effective for adults and children 6 months and older, expanding consumer options in a category where U.S. approvals have lagged behind other countries. The FDA said it is seeking public comment on the proposed order.
Finally, on December 12th, the FDA announced approvals of two new oral therapies for uncomplicated urogenital gonorrhea, a sexually transmitted infection increasingly challenged by drug resistance. The agency approved Nuzolvence (zoliflodacin) granules dissolved in water for adults and children 12 and older weighing at least 77 pounds, and approved Blujepa (gepotidacin) tablets for the same condition in patients 12 and older weighing at least 99 pounds who have few or no other treatment choices due to limited safety data. In studies cited by the FDA, Nuzolvence cured 91% of patients compared with 96% for standard therapy, while Blujepa cured 93% compared with 91% for standard therapy. The FDA said both drugs received Fast Track, Qualified Infectious Disease Product, and Priority Review designations, with Nuzolvence approved for Entasis Therapeutics and Blujepa for GSK.
Taken together, the announcements marked a concentrated stretch of FDA action—one that pairs faster review pathways and real-world data collection with high-stakes approvals for rare diseases and new infectious-disease treatments, while also taking aim at everyday consumer health products.
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