Early implementation of treatment with biologic or targeted synthetic DMARDs after methotrexate failure did not prevent the ...
Early initiation of biologic therapy in patients with Crohn’s disease (CD) is associated with higher rates of transmural healing and leads to improved long-term outcomes. In CD, early initiation of ...
The FDA received a biologics license application for accelerated approval of RP1 plus nivolumab for advanced, pretreated ...
Researchers observed responses in patients with synovial sarcoma or myxoid/round cell liposarcoma treated with lete-cel.
Replimune (REPL) announced that it has submitted a biologics license application, or BLA, to the FDA for RP1 in combination with nivolumab for ...
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FDA shares additional draft guidance on CGTs
The FDA has released a draft of new guidance addressing common FAQs about the development of potential CGT treatments.
Regenxbio has revealed plans to submit a biologics licence application (BLA) for RGX-202, its investigational gene therapy ...
The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for prademagene zamikeracel for the treatment of recessive dystrophic epidermolysis ...
Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.
Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision ...