Approved
Aldeyra hopes new data for dry-eye disease drug will satisfy FDA
United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application
PTC crashes as win for Novartis-partnered Huntington’s drug fails to convince investors
factor IX, PTC518, Accelerated, Approved, United States Food and Drug Administration
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