FDA

20 articles in the TruthFoundry index. Each links out to the original.

• FDA Approves First Gene Therapy for Glycogen Storage Disease Type Ia · FDA grants accelerated approval for Genglycos, the first gene therapy for GSDIa patients aged 8 and older.
• FDA Authorizes First Robotic Blood Draw Device to Address Staffing Shortage · FDA authorizes Aletta, the first standalone robotic device for hands-free blood draws in outpatient settings.
• FDA Seeks Public Input on Regulating GenAI Medical Devices · FDA launches public docket to shape regulations for generative AI-enabled medical devices.
• FDA Authorizes Simparica TRIO for New World Screwworm Treatment · FDA issues Emergency Use Authorization for Simparica TRIO to treat New World screwworm in dogs.
• FDA Authorizes CLiK Extra to Prevent New World Screwworm in Livestock and Wildlife · FDA issues Emergency Use Authorization for CLiK Extra spray to prevent New World screwworm infestations in livestock and wildlife.
• FDA Approves Tudriqev for Treatment-Resistant Advanced Melanoma · FDA grants accelerated approval to Tudriqev for unresectable advanced melanoma patients who progressed on PD-1 therapy.
• FDA Approves Orzeyful, First Drug to Treat Narcolepsy Type 1 · FDA approves Orzeyful, the first drug to directly restore orexin signaling for narcolepsy type 1.
• FDA Licenses First Freeze-Dried Plasma Product for Emergency Use · FDA approves Ezplaz, the first U.S. freeze-dried plasma product, for emergency transfusion in austere environments.
• FDA Selects Dexcom as First Participant in TEMPO Digital Health Pilot · The FDA selected Dexcom as the first manufacturer for its TEMPO pilot program for digital health devices.
• FDA Revokes Orange B and Proposes Revoking Citrus Red No. 2 · FDA issues final order revoking Orange B and proposes revoking Citrus Red No. 2 from food supply.
• FDA Approves First Oral PCSK9 Inhibitor Lipfendra for High Cholesterol · FDA approves Lipfendra, the first oral PCSK9 inhibitor, to lower LDL cholesterol in adults.
• FDA Authorizes Ivermectin for Short-Term New World Screwworm Prevention in Horses · FDA issues EUA for Ivermectin Liquid for Horses to prevent New World screwworm infestations.
• FDA Proposes Streamlined Registration for Distributed Drug Manufacturers · FDA proposes a rule to streamline registration for distributed manufacturing establishments and clarify requirements for foreign drug suppliers.
• FDA Approves First Gene Therapy for Children with Sickle Cell Disease · FDA grants supplemental approval for Casgevy gene therapy to children aged 2 and older with sickle cell disease.
• FDA Approves Tregzi to Reduce Chronic GVHD in Blood Cancer Patients · FDA approves Tregzi, the first Treg cell therapy, to improve GVHD-free survival in blood cancer transplant patients.
• FDA Selects Seven Companies for PreCheck Pilot to Boost U.S. Drug Manufacturing · The FDA selected seven companies to participate in a pilot program aimed at strengthening domestic pharmaceutical manufacturing.
• FDA Proposes Rule to Hold Foreign Tobacco Manufacturers Accountable · FDA proposes new rule requiring foreign tobacco manufacturers to register and list products to match domestic standards.
• FDA Approves First Generic Single-Dose Flu Treatment for 2026 Season · FDA approves first generic version of Xofluza, a single-dose flu treatment, ahead of the 2026–2027 season.
• FDA Approves OTC Naloxone Nasal Spray Rextovy to Expand Opioid Overdose Treatment · FDA approves Rextovy, an over-the-counter naloxone nasal spray, to broaden access for opioid overdose reversal.
• FDA Approves Tzield for Delaying Insulin Decline in Pediatric Stage 3 Type 1 Diabetes · FDA grants accelerated approval for Tzield to delay insulin decline in children with newly diagnosed Stage 3 type 1 diabetes.