FDA Updates
Providing FDA updates in the biotechnology space.
Seagen Announces U.S. FDA Approval of New Indication for ADCETRIS® (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma
“ADCETRIS is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical HL,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that supported this approval.”
ProciseDx Announces FDA Clearance of ProciseDx instrument and C Reactive Protein (CRP) Assay
ProciseDx has a menu of 5-minute gastroenterology and Therapeutic Drug Monitoring (TDM) tests available in Europe.
Cellevolve Bio Receives FDA Clearance of IND Application and Orphan Drug Designation for CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy
The safety and efficacy of CE-VST01-JC will be evaluated in ASCEND-JC, a global, multi-center, randomized, double-blind, placebo-controlled Phase 2 study that will enroll up to 60 patients across the US, Canada, and EU. The first patient enrolled is anticipated in the first half of 2023.
Noema Pharma Receives FDA Fast Track Designation for basimglurant (NOE-101) in Trigeminal Neuralgia
Fast Track designation aims at facilitating the development and expediting the review of drugs to treat serious conditions with clearly defined unmet medical needs, with the purpose to bring important new drugs to patients earlier advises Noema Pharma.
TeraImmune Receives FDA IND Clearance to Initiate Phase 1/2a Clinical Trial of TI-168 for Treatment of Hemophilia A with Refractory Inhibitors
The multi-center, open-label, Phase 1/2a study is designed to assess the safety and efficacy of TI-168 in up to eighteen congenital hemophilia A (HA) patients with refractory inhibitors.
Lilly Receives U.S. FDA Fast Track Designation for tirzepatide for the Treatment of Adults with Obesity, or Overweight with Weight-related Comorbidities
Based on discussions with the FDA, Lilly plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be based primarily on results from two Phase 3 clinical trials: SURMOUNT-1, which is complete, and SURMOUNT-2, which is expected to complete by the end of April 2023.