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News about "Fast Track Designation"
Johnson & Johnson Receives FDA Fast Track Designations for Treatment of Alzheimer's Disease
Posdinemab is the second Fast Track designation granted in 2024 for the Company’s AD portfolio.
Fast Track Designation | 10/01/2025 | By Aishwarya
Phanes Secures Fast Track Designation for PT217 from FDA
PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma, including neuroendocrine prostate cancer (NEPC).
Fast Track Designation | 05/12/2024 | By Aishwarya
Sun Pharma and Moebius Medical Receive FTD for MM-II for Treatment of Osteoarthritis Knee Pain
Sun Pharma and Moebius Medical have announced that the US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain.
Fast Track Designation | 07/09/2024 | By Aishwarya
Innovent Secures Fast Track Designation from FDA for IBI363
Innovent Biologics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein for the treatment of unresectable locally advanced or metastatic melanoma.
Fast Track Designation | 04/09/2024 | By Aishwarya
Clarity Secures FDA Fast Track Designation for 64Cu-SAR-bisPSMA
Clarity Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions.
Fast Track Designation | 23/08/2024 | By Aishwarya
Hinova Pharma Secures FDA Fast Track Designation for HP518
Hinova Pharmaceuticals Inc. has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC).
Fast Track Designation | 08/07/2024 | By Aishwarya | 172
SN Bioscience's SNB-101 Granted FDA Fast Track Designation for Small Cell Lung Cancer Treatment
SNB-101, previously designated as an orphan drug for SCLC and pancreatic cancer, has now received Fast Track designation, signaling a step towards potential commercialization following the completion of phase 2 clinical trials.
Fast Track Designation | 10/05/2024 | By Abha | 135
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