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FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation, Sets April 30 PDUFA Date

Axsome’s submission is backed by four Phase 3 studies alongside long-term safety data.

Takeda’s AI-Assisted Psoriasis Pill Succeeds in Phase 3, Outperforms Otezla

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS

Terns’ TERN-701 Shows Strong CML Responses in CARDINAL, Setting 320 mg and 500 mg Phase 2 Doses

Lilly’s Oral GLP-1 Orforglipron Beats Farxiga and Placebo in Two Phase 3 Diabetes Trials

FDA Approves Lurbinectedin Plus Atezolizumab for First-Line Maintenance in Extensive-Stage SCLC

Ionis’ Olezarsen Slashes Triglycerides, Cuts Pancreatitis in Phase 3 Trials

FDA Approves Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis