Regulating drug discovery and pharmaceutical manufacturing, the FDA ensures the safety and effectiveness of innovative therapies and medical devices.
References
2. Food allergies Current estimates indicate that up to 6% of the American population have a life-threatening food allergy. Since there is no cure for food allergies, most affected individuals must strictly avoid these food products and, in the event they are exposed, immediately receive epinephrine to prevent an anaphylactic reaction.
Originally approved in June 2023 under the FDA Accelerated Approval pathway, Elevidys is a recombinant gene therapy that utilizes a viral vector to deliver micro-dystrophin, a shortened version of the dystrophin gene. Following observations that Elvidys led to significant improvements in creatine kinase levels, as well as physical activities used to reflect skeletal muscle function, the FDA expanded the approval of Elvidys also to treat non-ambulatory patients four years of age and older.
In August 2024, the FDA approved Tecelra, which is a T-cell receptor gene therapy that is developed based on a patient’s T-cells, to treat adults with metastatic synovial sarcoma. These T-cells are subsequently modified to specifically target melanoma-associated antigen 4 , an antigen that is highly expressed in synovial sarcoma cells.4
As a result, the FDA has approved the use of updated messenger ribonucleic acid COVID-19 vaccines that contain a monovalent component that corresponds to the SARS-CoV-2 Omicron KP.2 subvariant.7
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