Identifier
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
Forging the Future of Cell Therapy: Bayer and BlueRock’s Unique Journey
cell therapy; Bayer; BlueRock Therapeutics; Parkinson’s disease; bemdaneprocel; biotech partnerships; RMAT designation; Phase 3 trials; regenerative medicine
Neurona nabs $102M to launch pivotal trial of epilepsy cell therapy
MTLE, Epilepsy, Cell Therapy, RMAT, Identifier, drug-resistant
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
Appeals Court Upholds FDA’s Denial of Fast Track Designation for Vanda’s Gastroparesis Drug
FDA, Vanda Pharmaceuticals, Fast Track Designation, Gastroparesis, Drug Approval Process
Corcept’s ALS Drug Trial Misses Primary Endpoint, Yet Shows Promising Survival Benefit
Corcept Therapeutics, Dazucorilant, ALS (Amyotrophic Lateral Sclerosis), Phase 2 trial, Survival benefit, Fast Track Designation, Cortisol modulator
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
Cybin’s Psychedelic Breakthroughs: Advancing Mental Health Treatments
Cybin, psychedelic therapeutics, mental health treatments, deuterated psilocybin, deuterated DMT, clinical trials, FDA Breakthrough Therapy Designation.