, Sept. 26, 2024 /PRNewswire/ -- PTC Therapeutics (NASDAQ: PTCT) announced today that the FDA has granted Fast Track designation to the PTC518 program for the treatment of Huntington's disease. Fast Track designation is awarded to promising therapies for diseases of high unmet need....
1. RemeGen’s RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients. News release. RemeGen. January 12, 2024. Accessed January 12, 2024. http://tinyurl.com/5h47am5h 2. RC88 in platinum-resistant recurrent epithelial ovarian...
FDA.Guidance for industry:fast track drug developmentprograms-designation,development and application review.. 2004US Department of Health and Human Services (2004) Guidance for industry: fast track drug development programs-designation, development, and application review. In: US Fo...
“With the upcoming maturation of the data from the 100-patient cohort with prior platinum-based and PD-1 or PD-L1 inhibitor therapies, and based on the Fast Track designation, we will actively seek guidance from the FDA on a potential accelerated approval pathway,” ...
GSK vaccines research and development global head Phil Dormitzer stated: “We welcome the FDA’s decision to grant fast track designation for our new vaccine candidate againstNeisseria gonorrhoeaeinfection. “This designation recognises the potential for a vaccine that could help protect millions of peo...
“The FDA is committed to continuing to provide regulatory flexibility and guidance, but let me make one thing clear: the FDA’s responsibility to the American people is to ensure that products are safe and effective,” he said. He said the FDA is expanding its work regarding potential ther...
SC291 CAR T-cell therapy targets relapsed/refractory SLE, receiving FDA Fast Track Designation, highlighting its potential as an off-the-shelf treatment. The GLEAM trial evaluates SC291's safety and efficacy in B-cell mediated autoimmune diseases, with initial data expected in 2025. SHOW MORE...
1Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More:https://www.fda.gov/patients/fast-track-breakthrough-therapy...
FDA’s Fast Track Designation for VBI-1901 underscores the significant and urgent unmet medical need for new therapies for recurrent glioblastoma (GBM) patients.
Oncologist Keith Flaherty says that the FDA lacks guidance on the therapy which could be advantageous for some drugs.LedfordHeidiNatureLedford H. Pharma scrambles to fast-track drugs. Nature 2013; 502: 20.