acceptance – Talk Bio

Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC

3 weeks ago talkbio0Tagged acceptance, ARROS-1 trial, Breakthrough Therapy, Clinical Nurse Specialists, Identifier, New Drug Application, Non-Small Cell Lung Carcinoma, Nuvalent, orphan drug designation, PDUFA, Penetration, pre-treated, Protein-tyrosine kinase inhibitor, ROS1-positive, United States Food and Drug Administration, zidesamtinib

Nuvalent; zidesamtinib; FDA acceptance; New Drug Application (NDA); ROS1-positive NSCLC; tyrosine kinase inhibitor (TKI) pre-treated; ARROS-1 trial; PDUFA date; CNS penetration; breakthrough therapy designation; orphan drug designation

Innovent’s IL-23 Drug Picankibart Shows Promising Results in Phase 3 Trial for Moderate to Severe Plaque Psoriasis

1 year ago talkbio0Tagged acceptance, Chinese Language, Clinical Trials, Dental Plaque, inhibitors, Innovent, interleukin-23, NDA, Phase 3, Phase 3, picankibart, Regulators (device)

Innovent Biologics, Picankibart, IL-23 inhibitors, Plaque psoriasis, Phase 3 clinical trial, Chinese regulators, NDA acceptance

Biotech Faces a Reckoning: The Challenges and Shifts in Cell Therapies

2 years ago talkbio0Tagged acceptance, Autoimmune Diseases, Cell Therapy, Drug Industry, gene therapy, Manufacture, Market

cell therapy, biotech, gene therapy, autoimmune diseases, manufacturing challenges, market acceptance, pharmaceutical industry