Browsing Tag
FDA
341 posts
Dizal’s sunvozertinib beats chemo in phase 3 first-line NSCLC trial, opening path to new drug applications
Dizal's sunvozertinib beats platinum chemo in WU-KONG28 phase 3 first-line EGFR exon 20 NSCLC trial. What this means for patients, rivals and investors. Read more.
Novo Nordisk strengthens obesity leadership with Wegovy HD FDA approval and higher-efficacy profile
Novo Nordisk secures FDA approval for Wegovy HD, boosting weight loss efficacy. Discover what this means for the obesity drug market.
Zydus (NSE: ZYDUSLIFE) unit Sentynl adds Korean progeria drug Progerinin to rare disease portfolio as Phase 2A data loom
Sentynl, Zydus Lifesciences' US subsidiary, licenses Progerinin from Korea's PRG S&T for progeria. Phase 2A data due H1 2026. Read the full analysis.
Structure Therapeutics (Nasdaq: GPCR) posts 16% weight loss with oral GLP-1 drug aleniglipron, setting up Phase 3 push
Structure Therapeutics' aleniglipron hits 16% weight loss at 44 weeks in Phase 2, matching injectables. Read the full analysis before Phase 3 begins.
GSK to sell linerixibat rights to Alfasigma for up to $690m as rare liver disease drug nears FDA approval
GSK and Alfasigma agree worldwide licence for linerixibat, a rare liver disease itch drug nearing FDA approval. Deal worth up to $690 million. Read more.
HIMS near 52-week low as FDA issues 30 GLP-1 warning letters
FDA sends 30 warning letters to GLP-1 compounders, targeting Hims & Hers Health (HIMS) as regulatory and legal pressure intensifies. Read what it means for investors and the sector.
Vanda Pharmaceuticals (VNDA) wins FDA’s first formal drug approval hearing in 40 years as Hetlioz jet lag battle enters new phase
FDA grants Vanda Pharmaceuticals a rare Part 12 public hearing on Hetlioz jet lag rejection, the first such drug approval hearing in 40 years. Read the full analysis.
Pfizer-backed Priovant wins FDA priority review for brepocitinib in dermatomyositis
FDA grants priority review to Priovant's brepocitinib NDA for dermatomyositis with a Q3 2026 PDUFA date. Read what this means for Roivant, Pfizer, and the autoimmune market.
The drug that could dethrone Voxzogo: FDA clears Ascendis Pharma’s navepegritide alfa for achondroplasia
FDA approves Ascendis Pharma's navepegritide alfa for achondroplasia, intensifying competition with BioMarin's Voxzogo. Read what this means for the rare disease market.
KEYNOTE-B96 final analysis: Merck’s Keytruda cuts death risk by 18% in recurrent ovarian cancer across all-comer population
Merck's Keytruda cuts death risk 18% in platinum-resistant ovarian cancer regardless of PD-L1 status. FDA approved, EU opinion positive. Read the full analysis.