Drug Development
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FDA Approves Otsuka's Simtriyo, the First Triple-Reuptake Inhibitor for ADHD in Adults and Children
Otsuka's Simtriyo (centanafadine) becomes the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, backed by four Phase 3 trials, with a boxed warning and DEA scheduling still pending.
Biogen's Tau-Targeting Diranersen Misses Its Primary Endpoint in Phase 2 but Cuts Brain Tau and Slows Alzheimer's Decline
Biogen's diranersen, an antisense drug aimed at tau, missed its Phase 2 dose-response endpoint but slowed cognitive decline and cut brain tau across all doses. Biogen is advancing to Phase 3.
Chai Discovery Raises $400 Million Series C at $3.8 Billion Valuation as Pfizer, Lilly and Novartis Deals Pile Up
AI drug-design startup Chai Discovery raised $400 million at a $3.8 billion valuation, nearly tripling its worth in seven months as Pfizer, Eli Lilly and Novartis sign on.
FDA Approves Subcutaneous Starting Dose for Leqembi Iqlik, Bringing At-Home Initiation to Early Alzheimer's Treatment
The FDA cleared a subcutaneous starting dose for Eisai and Biogen's Leqembi Iqlik, letting early Alzheimer's patients begin anti-amyloid treatment with a 15-second at-home injection instead of IV infusion.
Zanubrutinib-Rituximab Cuts Progression Risk 43 Percent in Frontline Mantle Cell Lymphoma in Phase 3 MANGROVE Trial
BeOne Medicines' chemo-free BRUKINSA plus rituximab regimen met its primary endpoint against bendamustine-rituximab in untreated mantle cell lymphoma.
Absentia Labs' AI 'Digital Liver' Becomes First AI Drug-Development Tool Accepted Into the FDA's ISTAND Program
Absentia Labs says its AI-driven Digital Liver Model is the first AI drug-development tool accepted into the FDA's ISTAND qualification pathway, at the Letter of Intent stage, to predict drug-induced liver injury.
Roche's Divarasib Beats Approved KRAS G12C Drugs Head-to-Head in Phase 3 Lung Cancer Trial
Roche says its next-generation inhibitor divarasib improved both progression-free and overall survival versus approved KRAS G12C drugs in a 338-patient Phase 3 NSCLC trial.
BridgeBio's Oral Infigratinib Adds 2.1 cm/Year of Growth in Achondroplasia Phase 3, Published in NEJM
PROPEL 3 met its primary endpoint, positioning infigratinib as a potential first oral rival to BioMarin's injectable Voxzogo. NDA filing is planned for Q3 2026.
FDA Approves Orca Bio's Tregzi, the First Regulatory T-Cell Therapy, to Cut Chronic GVHD After Stem-Cell Transplant in Blood Cancer
Tregzi lifted 12-month chronic-GVHD-free survival to 78% from 38% in the 187-patient Precision-T trial, becoming the first Treg-based immunotherapy the FDA has cleared.
Pfizer's Sigvotatug Vedotin Misses Overall Survival Goal in Phase 3 Lung Cancer Trial, Salvaging a Signal in Second-Line Patients
Pfizer's integrin beta-6 ADC failed to beat docetaxel on overall survival across the full SigVie-002 population, but showed a stronger trend in the two-thirds of patients with one prior line of therapy.
Merck's Tulisokibart Becomes First Anti-TL1A Antibody to Hit Phase 3 Remission Endpoint in Ulcerative Colitis
Merck says its TL1A antibody tulisokibart met the primary and key secondary endpoints in the Phase 3 ATLAS-UC induction study, a first for the drug class.
Bepirovirsen Delivers a Functional Cure in About One in Five Chronic Hepatitis B Patients in Phase 3 Trials
GSK's antisense drug bepirovirsen cleared chronic HBV in 20% and 19% of patients across two Phase 3 trials, versus none on placebo, the NEJM reports.