X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)
X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This DMF covers the Chemistry, Manufacturing and…
Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA)…
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)
Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the…
