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fast track designation

Showing 9 posts of 9 posts found.

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Duke Street Bio receives FDA fast track designation for brain metastases treatment

July 8, 2025
Medical 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) …

News

FDA approves Incyte’s new anal cancer treatment

May 20, 2025
Research 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 …

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AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA

July 26, 2024
Research 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) …

News

BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin

July 25, 2024
Medical 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, …

News

Quince Therapeutics gains FDA Fast Track Designation for EryDex System

June 4, 2024
Medical 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 …

News

GSK gains FDA Fast Track designation for chronic hepatitis B treatment

February 12, 2024
Medical 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 …

News

Alladapt Immunotherapeutics gains FDA Fast Track Designation for ADP101 as food allergy treatment

November 24, 2023
Research 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 …

News
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GSK receives FDA Fast Track designation for novel gonorrhoea vaccine

June 27, 2023
Research 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 …

News

Lundbeck, Otsuka’s trial Alzheimer’s disease drug gets US FDA fast track designation

July 8, 2016
Medical 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 …

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