Posts

RA Capital Launches Rare Disease Company Oak Hill Bio onto Nasdaq via SPAC

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FDA Accepts BridgeBio’s NDA for BBP‑418 as Potential First Limb‑Girdle Muscular Dystrophy Treatment

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Celcuity's Gedatolisib Achieves Phase 3 Success in PIK3CA-Mutant Breast Cancer as FDA Decision on Wild-Type NDA Nears

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Mirum Preps FDA Filing for Volixibat After Phase 2b Success in Reducing PSC Itch

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Xenon Pharmaceuticals' Azetukalner Achieves Phase 3 Success in Epilepsy Trial, Boosting Blockbuster Potential

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Biopharma Bites: FDA Reviews Roche and Teva NDAs, Candel Funding

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PTC Therapeutics Withdraws US NDA for Translarna in Nonsense Mutation Duchenne Muscular Dystrophy

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FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

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FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

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FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

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FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

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FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

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Immunome’s desmoid tumor drug varegacestat posts landmark Phase 3 results, setting up a potential challenge to Merck KGaA’s Ogsiveo

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Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST)

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