Nasdaq

Pyxis Oncology Announces Fast Track Designation from FDA for PYX-201 in Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Pyxis Oncology, Inc. announced that the FDA has granted Fast Track Designation for its drug PYX-201, aimed at treating adult patients with recurrent or metastatic head and neck squamous cell carcinoma ...
Nasdaq

Mersana Therapeutics Receives Additional FDA Fast Track Designation for XMT-1660 in Advanced Breast Cancer Treatment

Mersana Therapeutics, Inc. announced that the FDA has granted an additional Fast Track designation for its drug XMT-1660, also known as emiltatug ledadotin (Emi-Le), aimed at treating advanced or ...

Invivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID

NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an ...
Morningstar

MavriX Bio Receives FDA Fast Track Designation for MVX-220 for Treatment of Angelman Syndrome

MIDDLETON, Mass., Sept. 22, 2025 /PRNewswire/ -- MavriX Bio, a clinical-stage biotechnology company focused on the development of transformative genetic therapies for Angelman syndrome (AS), today ...
Seeking Alpha

Creative Medical Technology Holdings Secures FDA Fast Track Designation for CELZ-201-DDT - Advancing Breakthrough Therapy for Chronic Lower Back Pain

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today ...
Becker's Hospital Review

UW Health therapy secures FDA fast-track designation

An experimental cell therapy developed at the University of Wisconsin Health in Madison has received the FDA’s fast-track designation. The treatment, developed through a partnership between UW Health ...
Business Wire

PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with ...

Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)

Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancerSAN DIEGO and ...
Monthly Prescribing Reference

Implantable Stem Cell Therapy Fast Tracked for Crohn Disease Perianal Fistulas

AVB-114 consists of stem cells taken from a patient’s fat tissue seeded into a bioabsorbable plug that is inserted into the patient’s fistula. The Food and Drug Administration (FDA) has granted Fast ...
Cure Today

OBX-115 Receives FDA Fast Track Designation in Advanced Melanoma

OBX-115, a TIL cell therapy, received FDA Fast Track Designation for treating refractory or relapsed metastatic or locally advanced melanoma. Fast Track Designation facilitates the development and ...
Business Wire

Glycomine Receives FDA Fast Track Designation for GLM101 for the Treatment of PMM2-CDG

SAN CARLOS, Calif.--(BUSINESS WIRE)--Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, announced today that the U.S. Food and Drug Administration (FDA) ...
Healio

FDA grants fast-track designation to small molecule for Fragile X

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