Posts

FDA Staff Signal Replimune RP1 Melanoma Trial Failure, Slashing Stock

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FDA Rejects Hengrui-Elevar Liver Cancer Drug Combo for Third Time due to Manufacturing Concerns

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Sanofi's Tolebrutinib Receives EMA Backing for Nonrelapsing Progressive MS Despite FDA Rejection

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Replimune Lays Off 60% of Workforce After Second FDA Rejection of RP1 Melanoma Drug

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FDA Rejects Replimune's RP1 Melanoma Treatment for Second Time, Citing Unresolved Trial Issues

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FDA Grants Accelerated Approval to Denali's Avlayah for Hunter Syndrome, Defying Rare Disease Rejection Trend

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Aldeyra Therapeutics' Reproxalap Faces FDA PDUFA Extension to March 16, 2026 After Third Review Delay, Sparking Stock Concerns

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FDA Rejects Disc Medicine's Bitopertin for Rare Blood Disorder EPP Despite Commissioner's Priority Voucher

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REGENXBIO's Hunter Syndrome Gene Therapy RGX-121 Rejected by FDA

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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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Sanofi calls FDA rejection of potential MS blockbuster tolebrutinib “unexpected” amid evolving agency views on benefit–risk

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FDA Rejects Relacorilant for Cushing's Syndrome High Blood Pressure

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FDA Rejects Biohaven's Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure

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FDA Rejects CUTX-101 for Rare Copper Deficiency Due to Manufacturing Issues

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IO Biotech Sheds 50% of Staff After FDA Blocks Cancer Vaccine Approval Path

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Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy

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