The US Food and Drug Administration (FDA) has granted Fast Track Designation to Complement Therapeutics’ CTx001, the ...
The FDA has granted fast track designation to a vectorized antibody that targets RNA-binding proteins characteristic of ...
The FDA granted fast track status to VectorY’s VTx-002, an antibody gene therapy targeting TDP-43 protein aggregates in ALS.
Novartis received breakthrough therapy designation from the FDA for ianalumab, a monoclonal antibody aimed at treating Sjögren’s disease. Ianalumab works by depleting B cells and blocking BAFF-R ...
Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to ...
The RMAT designation is intended to expedite the development and evaluation of regenerative medicine therapies.
Stenoparib, targeting PARP1/2 and tankyrase 1/2, offers a unique mechanism for treating advanced ovarian cancer. The FDA's fast track designation facilitates expedited development and review, with ...
Adagene Inc. ADAG announced that the FDA has granted Fast Track designation to its lead clinical-stage immuno-oncology candidate, muzastotug (ADG126). The designation was granted to muzastotug in ...
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