Latest News for: fda fast track

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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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Ouro Medicines Receives U.S. FDA Fast Track Designation for Gamgertamig in Immune Thrombocytopenia and Autoimmune ...

Image Citizen Tribune 20 Jan 2026
Gamgertamig previously received Orphan Drug Designation (ODD) for development in immune thrombocytopenia and autoimmune hemolytic anemia ....
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Ouro Medicines Receives U.S. FDA Fast Track Designation for Gamgertamig in Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

PR Newswire 20 Jan 2026
Food and Drug Administration (FDA) Fast Track designation for development in the treatment of autoimmune hemolytic anemia (AIHA) and for immune thrombocytopenia (ITP) ... Receiving Fast Track designation ...
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Company enters 2026 with over $70 million in cash, two positive Phase 2 programs, FDA Fast Track Designation and runway well into 2027 (Form 8-K) (Incannex Healthcare Inc)

Public Technologies 14 Jan 2026
Company enters 2026 with over $70 million in cash, two positive Phase 2 programs, FDA Fast Track Designation and runway well into 2027 ... ● FDA Fast Track Designation granted for lead obstructive sleep apnea candidate IHL-42X.
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Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer

Business Wire 09 Jan 2026
Food and Drug Administration (FDA) has granted Fast Track designation for Enolen®, the Company’s ...
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Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD

PR Newswire 08 Jan 2026
Food and Drug Administration (FDA) has granted Fast Track Designation for CTx001, the company's lead gene therapy candidate for the treatment of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).
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INTENT Biologics Receives FDA Fast Track Designation for PEP Biologic™

Image Hastings Tribune 08 Jan 2026
ROCHESTER, Minn.--(BUSINESS WIRE)--Jan 8, 2026-- ... .
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858 Therapeutics Announces FDA Fast Track Designation for PARG Inhibitor ETX-19477 for the Treatment of ...

Image Hastings Tribune 08 Jan 2026
SAN DIEGO--(BUSINESS WIRE)--Jan 8, 2026-- ... .
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VectorY Therapeutics Receives FDA Fast Track Designation for VTx-002, a First-in-Class Vectorized Antibody Targeting Underlying ...

Business Wire 08 Jan 2026
Food and Drug Administration (FDA) has granted Fast Track Designation for VTx-002, a first-in-class ...
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Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy ...

Canada Newswire 08 Jan 2026
Food and Drug Administration (FDA) has granted Fast Track Designation for CTx001, the company's lead gene therapy candidate for the treatment of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).
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858 Therapeutics Announces FDA Fast Track Designation for PARG Inhibitor ETX-19477 for the Treatment of Patients with BRCA-Mutated, Platinum-Resistant Ovarian Cancer

Pharmiweb 08 Jan 2026
Food and Drug Administration (FDA) has granted Fast Track designation to ETX-19477, the company’s internally discovered PARG inhibitor ... “We are pleased that the FDA has granted Fast Track designation ...
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Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD (GIMV NV)

Public Technologies 08 Jan 2026
FDA Fast Track designation has been granted to CTx001 for Geographic Atrophy secondary to Age-related Macular Degeneration ... Food and Drug Administration (FDA) has granted Fast Track Designation for ...
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BeOne Medicines Granted U.S. FDA Fast Track Designation for BGB-B2033 as Treatment for Hepatocellular Carcinoma

Image Hastings Tribune 18 Dec 2025
SAN CARLOS, Calif.--(BUSINESS WIRE)--Dec 18, 2025-- ... .
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Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)

Nasdaq Globe Newswire 16 Dec 2025
Designation underscores the potential of SAFEbody�-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer ... .
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Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) ...

Nasdaq Globe Newswire 16 Dec 2025
Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet need ... .

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