Approved
FDA Approves Johnson & Johnson’s Imaavy: A New Treatment Option for Generalized Myasthenia Gravis
Imaavy, nipocalimab-aahu, FcRn blocker, generalized myasthenia gravis (gMG), FDA approval, Johnson & Johnson, autoimmune disease, IgG reduction
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
AbbVie’s Rinvoq cleared for giant cell arteritis in US
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids
Abeona’s $3.1M gene therapy wins FDA nod for rare skin disease
United States Food and Drug Administration, United States Food and Drug Administration, Infrequent, ZEVASKYN, Abeona, gene therapy, Dermatologic disorders, Hallopeau-Siemens Disease, Approved, Abeona ‘s
FDA approves Abeonas skin disease cell therapy
ZEVASKYN, United States Food and Drug Administration, Hallopeau-Siemens Disease, Approved, Wounds – qualifier, gene therapy, Abeona, Treating
Biohaven, after setbacks, sees shares jump with Oberland Capital funding agreement worth up to $600M
Biohaven, Oberland Capital, $600 million investment, troriluzole, spinocerebellar ataxia (SCA), non-dilutive funding, FDA approval, senior secured notes
Regeneron Secures EU Approval for Bispecific Antibody Lynozyfic, Positioning for Competition Against J&J and Pfizer
Regeneron, Lynozyfic, Bispecific Antibody, Multiple Myeloma, EU Approval, J&J, Pfizer, Oncology
Akeso’s PD-1 inhibitor notches inaugural FDA nod for nasopharyngeal cancer
United States Food and Drug Administration, Approved, Akeso, Nasopharyngeal carcinoma, PDCD1 gene, Inhibitor, Akeso ‘s, Anniko
Novavax’s COVID-19 jab looks to be on track for approval
Vaccines, COVID19 (disease), United States Food and Drug Administration, Approved, Novavax, Novavax ‘s, Novavax
Facing added pressure from Eli Lilly, Novo Nordisk submits for FDA approval of oral GLP-1 obesity drug
Nordisk, Obesity, Approved, Oral cavity, Glucagon-Like Peptide 1, Market, Pressure- physical agent, eli lilly, competition, Novo, semaglutide, United States Food and Drug Administration, United States Food and Drug Administration