Drug Approval: upcoming dates

Recent

• Health09/25/2026@HealthDesk

  FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill

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

  

  Starts 10/24/2025 5:25PM UTCCONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins87% CONFIDENCEOverall confidence: 87%How well the pin's source and references back up its dates.Weighted average of how firmly 5 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 better343 days agoBayer's^[1] release is stamped "24 October 2025 | 19:25 PM Europe/Amsterdam" and opens "Berlin, October 24, 2025 - Bayer announced today that the U.S. Food and Drug Administration (FDA^[2]) has approved elinzanetant".

  The FDA approves Bayer's Lynkuet (elinzanetant), the first drug to block both the NK1 and NK3 receptors, as a hormone-free treatment for moderate to severe hot flashes of menopause.

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• Health09/25/2026@HealthDesk

  FDA Approves Zurzuvae, the First Pill for Postpartum Depression

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

  

  Starts 08/04/2023CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins89% CONFIDENCEOverall confidence: 89%How well the pin's source and references back up its dates.Weighted average of how firmly 5 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 better3.2 years agoThe FDA^[1] news release is headed "For Immediate Release: August 04, 2023" and says "Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression".

  The FDA approves Sage Therapeutics' Zurzuvae (zuranolone), a 14-day course of once-daily pills and the first oral treatment for postpartum depression, while rejecting it for major depression.

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• Health09/25/2026@HealthDesk

  FDA Approves Opill, the First US Birth Control Pill Without a Prescription

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

  

  Starts 07/13/2023CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins90% CONFIDENCEOverall confidence: 90%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 better3.2 years agoThe FDA^[1] news release is headed "For Immediate Release: July 13, 2023" and says "Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use".

  The FDA approves Perrigo's Opill (norgestrel 0.075 mg), a progestin-only daily pill, for sale over the counter, making it the first oral contraceptive Americans can buy without a prescription.

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• Health09/25/2026@HealthDesk

  FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes

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

  

  Starts 05/12/2023CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins90% CONFIDENCEOverall confidence: 90%How well the pin's source and references back up its dates.Weighted average of how firmly 5 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 better3.4 years agoThe FDA^[1][2][3] news release is headed "For Immediate Release: May 12, 2023" and says "Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant)".

  The FDA approves Astellas' Veozah (fezolinetant), a once-daily 45 mg pill and the first neurokinin 3 receptor antagonist for moderate to severe menopausal hot flashes, giving women who cannot take hormones a new option.

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