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Monoclonal Antibodies

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

The decision could speed a regulatory ruling that would introduce the first at‑home, subcutaneous treatment option for moderate to severe TED.

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AstraZeneca’s Tozorakimab Hits Phase III Goal in COPD, Marking Third Positive Pivotal Trial

Apogee to Report 52-Week Phase 2 Data for Zumilokibart in Atopic Dermatitis Today

G-BA Finds No Added Benefit for Alzheimer’s Drug Leqembi in Germany

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

Sanofi Pushes Amlitelimab Toward 2026 Filings After Mixed Phase 3 Readouts

Zydus Launches Low-Cost Nivolumab Biosimilar Tishtha in India After Court Greenlight

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

Germany Rolls Out Donanemab for Early Alzheimer’s Patients

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

FDA Launches Roadmap to Phase Out Animal Testing in Drug Development

Pfizer's New Drug Shows Promise in Combatting Cancer-Related Weight Loss