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Monoclonal Antibodies

FDA Grants Breakthrough Therapy Designation to Biogen’s Litifilimab for Cutaneous Lupus

The status reflects Phase 2 evidence of reduced skin disease activity in patients with cutaneous lupus erythematosus.

Sanofi Pushes Amlitelimab Toward 2026 Filings After Mixed Phase 3 Readouts

AstraZeneca’s LATIFY Phase 3 Finds No Survival Benefit for Ceralasertib Plus Imfinzi in Pre-Treated NSCLC

FDA Approves Amgen’s Uplinza for Generalized Myasthenia Gravis

MoonLake Investors Face Dec. 15 Lead-Plaintiff Deadline in SDNY Securities Case

BioCryst to Acquire Astria in $700 Million Cash-and-Stock Deal to Bolster HAE Portfolio

Sanofi’s Amlitelimab Meets Phase 3 Goals in Eczema as Shares Fall on Tepid Efficacy

Novartis Ianalumab Meets Efficacy and Safety Goals in Phase 3 Sjögren’s Trials

One in Three Infants Received Preventive RSV Antibody in First Season, Study Finds