PDUFA: upcoming dates

Upcoming

• Health09/30/2026@ThePinGang

  FDA Decision Due on GSK's Bepirovirsen for Chronic Hepatitis B

  FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United StatesGSK

  

  Starts 10/26/2026SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins75% CONFIDENCEOverall confidence: 75%How well the pin's source and references back up its dates.Weighted average of how firmly 3 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or betterin 23 daysGSK's^[1][2] release states "October 26, 2026 assigned by FDA as PDUFA date" and its later release says a US decision is "expected from the FDA by 26 October 2026".

  The FDA has set 26 October 2026 as its priority-review goal date for GSK's bepirovirsen, an antisense drug aimed at a functional cure of chronic hepatitis B after two positive phase III B-Well trials.

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• Health09/25/2026@HealthDesk

  FDA Decision Due on Roche's Giredestrant for Early Breast Cancer

  Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesRoche

  

  Starts 11/30/2026SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins78% CONFIDENCEOverall confidence: 78%How well the pin's source and references back up its dates.Weighted average of how firmly 4 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or betterin 58 daysRoche's^[1] release says "The FDA is expected to make a decision on the approval by 30 November 2026", the PDUFA goal date set under Priority Review.

  The FDA is due to decide by 30 November 2026 whether to approve Roche's giredestrant, an oral SERD that cut the risk of recurrence or death by 30% versus standard hormone therapy in early ER-positive breast cancer.

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