Precigen Receives FDA Approval for First Immunotherapy for HPV-Related Recurrent Respiratory Papillomatosis

Precigen; FDA approval; Papzimeos; zopapogene imadenovec-drba; HPV; recurrent respiratory papillomatosis (RRP); immunotherapy; gene therapy; adenoviral vector; Breakthrough Therapy designation

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA

Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs

Kura Oncology’s Ziftomenib Achieves Phase 2 Success in AML, Paving Way for Dual-Track Phase 3 Program

Ziftomenib, Acute Myeloid Leukemia (AML), NPM1 mutation, KMT2A rearrangement, Phase 3 trials, KOMET-001, KOMET-017, Menin inhibitor, Breakthrough Therapy Designation

FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC

Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review