Posts

Celcuity shares fall as delayed breast cancer drug launch eclipses first US FDA approval

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Daiichi Sankyo Postpones FY2026 Earnings Announcement to May 11, Shares Plunge 10%

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FDA Delays Decision on Sanofi's Subcutaneous Sarclisa to July 23, 2026

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Trump Administration Indefinitely Delays Medicare Weight-Loss Drug Pilot Program

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Sanofi's Tolebrutinib Faces Phase 3 Failure in PPMS and FDA Delays in nrSPMS

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Sanofi’s multiple sclerosis drug tolebrutinib flunks Phase 3 in PPMS and faces another FDA PDUFA delay

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Bristol Myers Squibb Delays Cobenfy Alzheimer's Psychosis Trial Readout Due to Site Irregularities

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FDA Delays Decision on Ascendis' Dwarfism Drug by Three Months

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FDA Delays Denali's Hunter Syndrome Therapy Decision by Three Months

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Sanofi's MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review

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FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

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FDA Extends PDUFA Date for Regenxbio's Hunter Syndrome Gene Therapy RGX-121

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FDA Delays Blenrep Decision, Challenging GSK's Multiple Myeloma Comeback Plans

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Sen. Bill Cassidy Calls for Deferral of CDC Vaccine Meeting After RFK Jr. Panel Shakeup

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FDA Delays Decision on KalVista's HAE Drug Sebetralstat, Citing Heavy Workload

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FDA Delays Decision on Biohaven's Troriluzole for Rare Disease, Plans Advisory Committee Review

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FDA delays decision date on Cytokinetics' heart drug to year-end in unusual safety program back-and-forth

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Novavaxs held-up approval package may signal warning for Covid vaccine makers

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