FDA

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

• FDA launches Rare Disease Framework Initiative to reform rare disease drug development · US FDA announces new Rare Disease Framework Initiative and opens public feedback period.
• FDA Expands Anktiva Approval For BCG-Unresponsive Bladder Cancer · FDA approves Anktiva as first treatment for BCG-unresponsive high-grade papillary bladder cancer.
• FDA Approves First Growing Heart Valve for Children · FDA approves Autus Size-Adjustable Valve, the first pediatric heart valve designed to expand with a child's growth.
• FDA Launches Nationwide Recruitment for Advisory Committee Members · FDA seeks qualified scientific and consumer experts for its advisory committees through a new nationwide recruitment effort.
• FDA Approves Emcitate, First Treatment For Rare MCT8 Deficiency · US FDA approved Emcitate, the first ever treatment for MCT8 genetic deficiency.
• FDA Plans to Evaluate Changes to Tobacco Product Regulatory Framework · The FDA intends to evaluate changes to the PMTA regulatory framework based on implementation experience and legal developments.
• FDA Wins Consent Decree Against Gold Star Distribution Over Warehouse Sanitation Violations · Federal court issues permanent injunction against Gold Star Distribution for insanitary warehouse conditions.
• FDA Issues Final Rule Allowing Non-Animal Drug Safety Testing · FDA published final rule permitting non-animal methods for human drug safety evaluations.
• FDA Approves First Gene Therapy for Sanfilippo Syndrome Type A · The FDA approved Fayuvi, the first gene therapy for pediatric patients with Sanfilippo syndrome type A.
• FDA Issues Temporary Policies to Ensure Newborn Nutrition Access · FDA issues immediate guidance to prevent supply gaps in neonatal parenteral nutrition products.
• FDA Grants Accelerated Approval For New Advanced Breast Cancer Treatment · US FDA approved Etcamah combination therapy for HR-positive metastatic breast cancer patients.
• FDA Approves Zanvastro, First Treatment for Rare Alexander Disease · FDA approved Zanvastro, the first drug targeting the root cause of Alexander disease.
• FDA Issues Emergency Authorization for Screwworm Pet Medications · FDA authorizes Capstar and generic nitenpyram for New World screwworm prevention in dogs and cats.
• FDA Seeks Public Input to Advance Botanical Drug Development · The FDA is requesting public feedback to improve the development and regulation of botanical drug products.
• FDA Approves Mimrylo, First Hepcidin-Mimicking Drug for Polycythemia Vera · The FDA approved Mimrylo (rusfertide), the first drug mimicking hepcidin to treat polycythemia vera.
• FDA Approves Lisraya As First Oral Adult Dermatomyositis Treatment · US FDA approves Lisraya, the first oral drug for adult dermatomyositis.
• FDA Issues Emergency Use Authorization For Generic Cattle Screwworm Drug · US FDA granted EUA for Bimectin injection to prevent New World screwworm in cattle.
• FDA Approves Rasonque (daraxonrasib) for Advanced Pancreatic Cancer · FDA approved Rasonque (daraxonrasib), a RAS inhibitor, for advanced pancreatic cancer months ahead of schedule.
• FDA Authorizes First Wearable to Continuously Monitor Ketones and Blood Sugar · FDA authorizes Libre Duo 10 Day, the first wearable device to continuously monitor both ketone and glucose levels.
• FDA Approves Genglycos Gene Therapy for Glycogen Storage Disease Type Ia · FDA gave Ultragenyx's Genglycos accelerated approval to reduce cornstarch intake in GSDIa patients aged 8 and older.
• FDA Authorizes Aletta, First Standalone Robotic Blood Draw Device · FDA authorizes Aletta, the first standalone robotic device for automated blood draws in outpatient settings.
• FDA Seeks Public Input on Regulating Generative AI Medical Devices · FDA launches public docket to shape regulatory framework for GenAI-enabled medical devices.
• FDA Grants Emergency Use Authorization for Simparica TRIO Against Screwworm in Dogs · US FDA issued EUA for Simparica TRIO to treat New World screwworm in dogs on 2026-08-13.
• FDA Issues Emergency Authorization for CLiK Extra Against New World Screwworm · US FDA granted EUA for CLiK Extra spray to prevent New World screwworm animal infestations.
• FDA Grants Accelerated Approval For Refractory Melanoma Immunotherapy · US FDA approved Tudriqev viral therapy for treatment-resistant advanced melanoma on 2026-08-06.
• FDA Approves First Full Symptom Narcolepsy Type 1 Drug · FDA approved Orzeyful, first drug targeting the root cause of narcolepsy type 1.
• FDA Licenses First United States Freeze-Dried Plasma Product · US FDA approves Ezplaz, the first licensed freeze-dried plasma for emergency remote use.
• FDA selects Dexcom as first participant in TEMPO digital health pilot · FDA named Dexcom the first manufacturer selected for the TEMPO digital health devices pilot.
• FDA Revokes Orange B Food Color, Proposes Ending Citrus Red No. 2 Authorization · US FDA announced revoking Orange B and proposing revocation of Citrus Red No. 2 food color additives.
• FDA Approves First Oral PCSK9 Inhibitor Lipfendra for High Cholesterol · FDA approves Lipfendra, the first oral PCSK9 inhibitor, to lower LDL cholesterol in adults with hypercholesterolemia.