Browsing Tag
FDA
316 posts
FDA approves Lilly’s Foundayo as second oral GLP-1 weight loss pill, challenging Novo Nordisk’s head start
FDA approves Eli Lilly's Foundayo (orforglipron), the second oral GLP-1 obesity pill with no food restrictions. What this means for LLY investors and patients. Read more.
Optiscan Imaging (ASX: OIL) files FDA dossier for InSpecta veterinary device, targeting an $11.9bn market
Optiscan Imaging (ASX: OIL) has filed its FDA dossier for InSpecta, targeting the US$11.9bn U.S. veterinary market. Read what this milestone means for investors.
Why VG801 could reshape endpoint strategy in inherited retinal disease development
VG801 shows early vision gains in Stargardt disease. Discover how VeonGen Therapeutics is redefining endpoints and regulatory strategy.
Verana Health and Guardant Health link genomics and real-world data to accelerate precision oncology drug
Verana Health and Guardant Health (GH) combine EHR and genomic data to accelerate oncology drug development. Read the full strategic analysis.
Bristol Myers Squibb (NYSE: BMY) expands Opdivo into frontline Hodgkin lymphoma, strengthening immuno-oncology leadership
Bristol Myers Squibb expands Opdivo in Hodgkin lymphoma. Discover how this reshapes treatment strategy, competition, and long-term oncology trends.
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.