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FDA Grants Priority Review to Ifinatamab Deruxtecan for Pretreated Small Cell Lung Cancer

Real-Time Oncology Review and Project Orbis will speed and coordinate evaluation of the B7-H3 antibody–drug conjugate.

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

Zealand Plunges as Roche Obesity Drug Posts 10.7% Weight Loss With Placebo‑Like Tolerability

Valneva Pulls U.S. Filings for Chikungunya Vaccine as FDA Halts Trials Over Safety Review

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

Lilly Reports Zepbound Plus Taltz Beat Taltz Alone in Psoriatic Arthritis Trial

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

Lilly’s Triple‑Agonist Retatrutide Delivers Up to 28.7% Weight Loss in Phase 3, Easing Knee Pain

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

Roche’s Giredestrant Cuts Early Breast Cancer Recurrence 30% in Phase III Trial

Pharvaris’ Oral HAE Drug Deucrictibant Delivers Rapid Relief in Pivotal Phase 3

FDA Outlines 'Plausible-Mechanism' Pathway to Speed Bespoke Therapies

Lilly to Launch Late-Stage Trials of Amylin Obesity Drug After 20% Weight Loss in Mid-Stage Study

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

FDA Clears Monthly Uzedy Injection for Maintenance Treatment of Bipolar I Disorder

FDA Opens Door to Reconsider Capricor’s Duchenne Cell Therapy Based on HOPE-3 Data

Bristol Myers’ Iberdomide Combo Hits MRD Goal in Phase 3 Myeloma Study

FDA Approves Keytruda QLEX, a Rapid Subcutaneous Option for Most Adult Solid Tumor Uses

FDA Approves First New Fibromyalgia Treatment in 15 Years