Nouscom Receives U.S. FDA Fast Track Designation for NOUS-209, a Novel Immunotherapy for the Prevention of Lynch Syndrome-Associated Cancers

Fast Track Designation (FTD) recognizes NOUS-209’s potential to address a serious condition with significant unmet medical need in Lynch Syndrome ...
Pharmaceutical Technology on MSN

Autobahn’s elunetirom receives FDA fast track designation to treat adjunctive bipolar

Autobahn expects topline data from the ongoing Phase II AMPLIFY-BD trial in adjunctive bipolar depression in the second ...
Rutland Herald

Autobahn Therapeutics Announces U.S. FDA Fast Track Designation for Elunetirom, a CNS-Directed Thyroid Hormone Receptor Agonist, for the Adjunctive Treatment of Bipolar Depression

Autobahn Therapeutics, Inc., a biotechnology company developing restorative treatments for people affected by neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration ...

Solu Therapeutics Granted FDA Fast Track Designation for STX-0712 for Treatment of Chronic Myelomonocytic Leukemia

Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, ...
Targeted Oncology

FDA Grants Fast Track Designation to STX-0712 for R/R CMML

Fast track status supports expedited development/review for a serious hematologic malignancy with limited second-line therapy after HMA failure. CyTAC engineering merges small-molecule CCR2 binding ...
Business Wire

Avenzo Therapeutics Granted Fast Track Designation for AVZO-103, a Potential Best-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with ...

SAN DIEGO--(BUSINESS WIRE)--Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the U.S. Food and Drug ...
Yahoo Finance

Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1

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Monthly Prescribing Reference

Posdinemab Receives Fast Track Designation for Early Alzheimer Disease

Posdinemab is currently being investigated in the phase 2b AuTonomy study, which enrolled 523 participants with early Alzheimer disease. The Food and Drug Administration (FDA) has granted Fast Track ...
Cure Today

FDA Grants Fast Track Designation to ADCE-D01 for Soft Tissue Sarcoma

ADCE-D01 targets the uPARAP protein in sarcomas, delivering medication directly to cancer cells, showing promise in early studies. The ADCElerate1 trial evaluates ADCE-D01's safety, tolerability, ...
Nasdaq

Affimed Receives FDA Fast Track Designation for AFM13 in Combination with AlloNK® for the Treatment of Patients with Relapsed or Refractory Hodgkin Lymphoma

MANNHEIM, Germany, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ...