fast track designation
Duke Street Bio receives FDA fast track designation for brain metastases treatment
July 8, 2025Medical Communications, Research and Development Duke Street Bio, Oncology, US Food and Drug Administration, brain metastases, breast cancer, fast track designation
Duke Street Bio, a biotech company based in London, UK, has announced that the US Food and Drug Administration (FDA) …
FDA approves Incyte’s new anal cancer treatment
May 20, 2025Research and Development FDA, Incyte Corporation, Oncology, Orphan Drug Designation (ODD), Zynyz, fast track designation, priority review
The US Food and Drug Administration (FDA) has approved Incyte Corporation’s immunotherapy retifanlimab-dlwr (Zynyz) in combination with carboplatin and paclitaxel to treat …
AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA
July 26, 2024Research and Development AC Immune, Alzheimer's disease, Neurology, clinical trials, fast track designation, immunotherapy, tau protein
Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) …
BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin
July 25, 2024Medical Communications BioAtla, FDA, Oncology, fast track designation, ozuriftamab vedotin
BioAtla has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, …
Quince Therapeutics gains FDA Fast Track Designation for EryDex System
June 4, 2024Medical Communications EryDex, FDA, Quince Therapeutics, Rare Diseases, fast track designation
Quince Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its EryDex …
GSK gains FDA Fast Track designation for chronic hepatitis B treatment
February 12, 2024Medical Communications FDA, GSK, Hepatology, fast track designation, hepatitis B
GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational …
Alladapt Immunotherapeutics gains FDA Fast Track Designation for ADP101 as food allergy treatment
November 24, 2023Research and Development Alladapt Immunotherapeutics, Allergic Disorders, FDA, fast track designation, food allergy
Alladapt Immunotherapeutics has announced that ADP101 has received Fast Track Designation from the US Food and Drug Administration (FDA) as …
GSK receives FDA Fast Track designation for novel gonorrhoea vaccine
June 27, 2023Research and Development FDA, GSK, Infections and infestations, Vaccine, fast track designation, gonorrhoea
GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for its investigational vaccine …
Lundbeck, Otsuka’s trial Alzheimer’s disease drug gets US FDA fast track designation
July 8, 2016Medical Communications, Research and Development Alzheimer's disease, Lundbeck, Otsuka, US FDA, drug development, drug trial, fast track designation
H. Lundbeck A/S (CPH: LUN) and Otsuka Pharmaceutical said the US Food and Drug Administration (FDA) have granted Fast Track …
