The FDA's Fast Track designation is designed to speed up the journey from development to approval for therapies that tackle serious conditions and meet previously unfulfilled medical needs. To learn…
In July 2023, the U.S. FDA granted Orphan Drug designation to ABM-1310, an investigational treatment option for people living with malignant gliomas such as glioblastoma. Now, reports clinical-stage biopharmaceutical…
In the United States, the FDA grants Fast Track designation to drugs that treat rare and serious conditions or fill unmet needs. The designation helps to facilitate and expedite the…
The U.S. Food and Drug Administration offers various designations to drugs and drug developers to both incentivize medical advancements in the rare disease space and get treatments in the…
Gene therapy has the potential to improve outcomes among individuals across various disease spectrums. In the case of clinical-stage biotechnology company Rocket Pharmaceuticals, the company is working to develop…
In late May 2023, clinical-stage biopharmaceutical company Sangamo Therapeutics, Inc. (“Sangamo”) shared that its product isaralgagene civaparvovc (ST-920) was granted Fast Track Designation by the FDA. This designation is…
In the United States, Fast Track designation is granted to drugs designed to treat rare and/or serious conditions and that fill an unmet medical need. The process aims to…
A January 2023 news release from biopharmaceutical company Avidity Biosciences, Inc. ("Avidity") shares that the company's therapy, AOC 1020, earned Fast Track designation from the FDA for the treatment of…
In the United States, Fast Track is the process designed to facilitate the development, and speed up the review, of therapies designed to fill an unmet need or treat…
For some patients with NF2-deficient malignant pleural mesothelioma (MPM), their cancer is unresectable, meaning that it cannot be surgically removed. Finding a way to better treat and assist these…
Fast Track designation is designed to facilitate the development of, and expedite the review of, drugs intended to treat serious conditions and fill unmet patient needs. This designation comes alongside…
Alzheimer’s disease is the primary cause of the progressive decline of cognitive function in the elderly. It is characterized by underlying complications in the central nervous system (CNS). To date,…
The Food and Drug Administration (FDA) has four distinct approaches to expedite the availability of therapies for rare, severe, or life-threatening illnesses: Priority Review, Breakthrough Therapy, Fast Track, and Accelerated…
Fast Track designation is granted by the FDA to facilitate the development and expedite the review of drugs to both fill unmet needs and treat serious or life-threatening conditions. Through…
Currently, there are few effective therapeutic options for patients with MuSK antibody-positive myasthenia gravis (MG). A majority of those with MG have autoantibodies targeting the acetylcholine receptor. As a result, acetylcholinesterase…
Sometimes, treatments used in conjunction with each other can confer benefits for patients. According to the Cancer Network, for example, treating platinum-resistant ovarian cancer using nemvaleukin alfa and pembrolizumab (Keytruda)…
In the United States, Fast Track designation is granted to help expedite drug development and review for serious, rare, or life-threatening conditions. To receive Fast Track designation, the treatment must…
According to a relatively recent news release from biopharmaceutical company Applied Therapeutics, Inc., AT-007 received Fast Track designation from the FDA. This therapy, which has also received both Orphan Drug…
Currently, there are no real treatments for patients with primary mitochondrial myopathy (PMM). Most therapies, such as physical, occupational, or speech therapy, are designed to simply lessen or mitigate symptoms.…
According to corporate news shared on Street Insider, biopharmaceutical company BridgeBio Pharma, Inc. ("BridgeBio") is making ground with its AAV5 gene therapy, BBP-631. Recently, the FDA granted Fast Track designation…
In a recent press release, biotechnology and gene therapy company LEXEO Therapeutics ("LEXEO") shared that its gene therapy LX1001 received Fast Track designation from the FDA. Overall, LX1001 is…
In late March 2021, the FDA gave Fast Track designation to annamycin. The treatment, initially developed for patients with acute myeloid leukemia (AML), is now being explored for patients with…
In a recent news release, biopharmaceutical company FibroGen, Inc. ("FibroGen") shared that its therapeutic candidate, pamrevlumab, received Fast Track designation from the FDA. The anti-CTGF antibody is designed to treat…
In early February, pharmaceutical company Ellodi Pharmaceuticals ("Ellodi") shared that its drug candidate, APT-1011, received the FDA's Fast Track designation. APT-1011, or fluticasone propionate oral disintegrating tablet, is designed to…
Recently, specialty pharmaceutical company Xeris Pharmaceuticals ("Xeris") announced that its injectable treatment XP-0863 received Fast Track designation for the treatment of patients with acute repetitive seizures. Xeris created this treatment…
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