Fda Fast Track

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Aktis Oncology Receives U.S. FDA Fast Track Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate

Nasdaq Globe Newswire 24 Feb 2026

Food and Drug Administration (FDA) has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial ...

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Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer (IP Group plc)

Public Technologies 24 Feb 2026

The FDA's Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.

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Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for ...

Nasdaq Globe Newswire 23 Feb 2026

Artios receives FDA Fast Track designation for DNA polymerase theta (Polθ) inhibitor ART6043 for treatment of gBRCA-mutated HER2-negative breast cancer ... .

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Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In ...

Nasdaq Globe Newswire 23 Feb 2026

Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, ...

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Pilatus Biosciences Receives FDA Fast Track Designation for Metabolic Checkpoint Inhibitor PLT012 in Hepatocellular Carcinoma

The Galveston Daily News 19 Feb 2026

DOVER, Del. & EPALINGES, Switzerland--(BUSINESS WIRE)--Feb 19, 2026-- ....

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99mTc-maraciclatide Granted FDA Fast Track Designation for the Visualization of Inflammation in Interstitial Lung Disease

The Facts 12 Feb 2026

12, 2026 /PRNewswire/ -- Serac Healthcare Limited, a ...

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Oncolytics Biotech� Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Nasdaq Globe Newswire 04 Feb 2026

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population ... .

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Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy Program

Citizen Tribune 04 Feb 2026

Food and Drug Administration (FDA) has granted Fast Track ...

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Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer (Form 8-K) (Oncolytics Biotech Inc)

Public Technologies 04 Feb 2026

) Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer ... Food and Drug Administration ("FDA") has granted Fast Track ...

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Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy Program (Form 8-K) (Cumberland Pharmaceuticals Inc)

Public Technologies 04 Feb 2026

) Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy Program ... Food and Drug Administration (FDA) has granted Fast Track Designation for its ...

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MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on ...

Nasdaq Globe Newswire 02 Feb 2026

... next-level therapies for inflammatory diseases, today announces that the FDA has granted Fast Track designation for sonelokimab for the treatment of moderate‑to‑severe PPP.

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QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

Nasdaq Globe Newswire 29 Jan 2026

Food and Drug Administration (FDA) has granted Fast Track designation to ...

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Drug Farm Announces FDA Fast Track Designation for First-in-Class ALPK1 Inhibitor DF-003 for the Treatment ...

Business Wire 28 Jan 2026

ALBANY, N.Y. & SHANGHAI--(BUSINESS WIRE)--FDA fast tracks DF-003 for ROSAH syndrome, announces Drug Farm ... .

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Leads Biolabs’ GPRC5D/CD3 Bispecific T-Cell Engager LBL-034 Earns FDA Fast Track Designation—Accelerating Launch of Potential ...

GetNews 28 Jan 2026

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening condition or address unmet medical needs to facilitate the development of drugs.

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BioNTech Receives FDA Fast Track Designation for mRNA Cancer Immunotherapy Candidate BNT113 in HPV16+ Head and Neck Cancer (BioNTech SE)

Public Technologies 21 Jan 2026

The FDA Fast Track process is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need.

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Latest News for: fda fast track

Aktis Oncology Receives U.S. FDA Fast Track Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate

Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer (IP Group plc)

Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for ...

Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In ...

Pilatus Biosciences Receives FDA Fast Track Designation for Metabolic Checkpoint Inhibitor PLT012 in Hepatocellular Carcinoma

99mTc-maraciclatide Granted FDA Fast Track Designation for the Visualization of Inflammation in Interstitial Lung Disease

Oncolytics Biotech� Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy Program

Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer (Form 8-K) (Oncolytics Biotech Inc)

Cumberland Pharmaceuticals Receives FDA Fast Track Designation for its Ifetroban Duchenne Muscular Dystrophy Program (Form 8-K) (Cumberland Pharmaceuticals Inc)

MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on ...

QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia

Drug Farm Announces FDA Fast Track Designation for First-in-Class ALPK1 Inhibitor DF-003 for the Treatment ...

Leads Biolabs’ GPRC5D/CD3 Bispecific T-Cell Engager LBL-034 Earns FDA Fast Track Designation—Accelerating Launch of Potential ...

BioNTech Receives FDA Fast Track Designation for mRNA Cancer Immunotherapy Candidate BNT113 in HPV16+ Head and Neck Cancer (BioNTech SE)

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