“The BLA acceptance is a significant milestone in our mission to deliver lifileucel as the first individualized, one-time cell therapy for a solid tumor. The FDA’s commitment to a 6-month priority review validates the unmet need and urgency for new treatment options for patients with advance...
(including from the prior pre-BLA meeting with the FDA); the risk that the FDA may not accept the BLA submission for lifileucel in metastatic melanoma, and even if the BLA submission is accepted for review, the FDA ultimately may not approve the BLA; the acceptance by the mar...
1.Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma.https://www.sec.gov/Archives/edgar/data/1651407/000110465923027655/tm238273d1_ex99-1.htm. 2.Berdazimer.DerNet.https://dermnetn...
1.Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma.https://www.sec.gov/Archives/edgar/data/1651407/000110465923027655/tm238273d1_ex99...
11.Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease.PR Newswire.25.10.2023. 12.CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel(exa-cel)for Severe Sickle Cell Disease...
Orchard Therapeutics recently announced the US FDA has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic
sensitivity and capability to detect a greater range of potential HCPs compared to the current assay and to implement this assay for drug substance release. The analytical procedure, validation report, proposed acceptance criterion, and data used to set ...
“Acceptance of the BLA filing is an important milestone for Autolus and we look forward to continuing our collaboration with the FDA during the review cycle,” said Christian Itin, PhD, chief executive officer of Autolus, in a press release.“With the PDUFA date set for November, we remai...
11.Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease.PR Newswire.25.10.2023. 12.CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel(exa-cel)for Severe Sickle Cell Disease...
1.Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma.https://www.sec.gov/Archives/edgar/data/1651407/000110465923027655/tm238273d1_ex99-1.htm. ...