Ad
related to: breakthrough therapy wikipedia full name search free for business license
Search results
Results From The WOW.Com Content Network
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
Treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy; and adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior ...
What links here; Related changes; Upload file; Special pages; Permanent link; Page information; Cite this page; Get shortened URL; Download QR code
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Suzetrigine, sold under the brand name Journavx, is a medication used for the management of pain. [1] [2] It is a non-opioid, small-molecule analgesic that works as a selective inhibitor of Na v 1.8-dependent pain-signaling pathways in the peripheral nervous system, [3] [4] avoiding the addictive potential of opioids.
A phase III study indicated that MDMA-assisted therapy represents a potential breakthrough treatment for severe PTSD that merits expedited clinical evaluation. [17] Based on this study, MDMA-assisted psychotherapy was granted breakthrough therapy designation by the FDA, a designation that indicates that there is preliminary evidence that an intervention might offer a substantial improvement ...
Axicabtagene ciloleucel (KTE-C19, ZUMA-3, YESCARTA) was an investigational therapy (for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL)) in which a patient's T cells were genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. [11]
In 2018, the United States Food and Drug Administration (FDA) granted breakthrough therapy designation for psilocybin-assisted therapy for treatment-resistant depression. [28] [29] A systematic review published in 2021 found that the use of psilocybin as a pharmaceutical substance was associated with reduced intensity of depression symptoms. [30]