SAN DIEGO, June 09, 2021 (GLOBE NEWSWIRE) Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that the U.S. Food and Drug Administration .
71% of Adult Patients in Phase 2 ZUMA-3 Study Achieved a Complete Response Following a Single Infusion of Tecartus - If Approved, Tecartus Would Be the First and Only CAR T-Cell Therapy Approved for Adult Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia Kite, a Gilead Company announced today results from the primary analysis of ZUMA-3, a global, multicenter, single-arm, .
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Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applications (“INDs”) or marketing applications, wind down production, or risk running afoul of applicable laws and regulations governing unapproved biological products. They should also be mindful of how data collected to date can help to inform next steps.