Health09/25/2026@HealthDesk
FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill
BayerMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 10/24/2025 5:25PMCONFIRMED 87% CONFIDENCE336 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.
0.82
Health09/25/2026@HealthDesk
FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 12/16/2024CONFIRMED 87% CONFIDENCE1.8 years agoThe FDA^[1][5] drug safety communication carries the entry "12-16-2024 Update: FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury".
The FDA adds a boxed warning, its most prominent, to Astellas' hot-flash pill Veozah after a patient suffered serious liver injury within about 40 days of starting it, and orders monthly liver tests for the first months.
0.75
Health09/25/2026@HealthDesk
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Sage TherapeuticsMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 08/04/2023CONFIRMED 89% CONFIDENCE3.1 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.
0.73
Health09/25/2026@HealthDesk
FDA Approves Opill, the First US Birth Control Pill Without a Prescription
PerrigoMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 07/13/2023CONFIRMED 90% CONFIDENCE3.2 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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Health09/20/2026@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli LillyIndianapolis, Indiana
Starts 04/01/2026CONFIRMED 85% CONFIDENCE177 days agoLilly^[3] and the FDA^[4] approval letter date the approval April 1, 2026.
The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
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Health09/25/2026@HealthDesk
FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning
U.S. Food and Drug AdministrationMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 02/12/2026CONFIRMED 84% CONFIDENCE225 days agoThe FDA^[1][4] news release is headed "For Immediate Release: February 12, 2026" and says the FDA "has approved drug labeling changes to six menopausal hormone therapy products".
The FDA approves new labels for six menopausal hormone therapy products, one from each class, that drop the cardiovascular, breast cancer and dementia statements from the boxed warning; 29 companies have filed changes.
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Health09/25/2026@HealthDesk
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
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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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Health09/23/2026@HealthDesk
Lilly Submits Retatrutide to the FDA for Approval
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
Starts 03/31/2027ESTIMATED3 months late77% CONFIDENCEin 187 daysLilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]
Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.
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Health09/23/2026@HealthDesk
FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis
Johnson & JohnsonSpring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United States
Starts 03/17/2026 8:12PMCONFIRMED 88% CONFIDENCE192 days agoThe FDA's^[4] approval letter for NDA 220149 says the application "is approved, effective on the date of this letter" and was electronically signed "03/17/2026 04:12:23 PM" (Eastern, 20:12 UTC); J&J announced it the next morning: "SPRING HOUSE, Pa. (March 18, 2026) - ... announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE".
The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.
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Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
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Roche's phase 3 trial of Enicepatide in obesity or overweight reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
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Health09/25/2026@HealthDesk
FDA Approves Evita Solutions' Generic Mifepristone
Evita SolutionsMahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United States
Starts 09/30/2025 2:20PMCONFIRMED 83% CONFIDENCE360 days agoThe ANDA 216616 approval letter says "the ANDA is approved, effective on the date of this letter" and is digitally signed "Date: 9/30/2025 10:20:02AM".^[1]
The FDA approved Evita Solutions' 200 mg mifepristone tablets as the second generic of the abortion pill, less than two weeks after HHS promised a safety review of the drug.
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Health09/23/2026@HealthDesk
FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer
Eli LillyBowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States
Starts 09/18/2026CONFIRMED 85% CONFIDENCE7 days agoLilly's release is datelined "INDIANAPOLIS, Sept. 18, 2026" and says it "announced today that the U.S. Food and Drug Administration (FDA^[4]) has granted full approval"; the FDA's own notice gives the approval date as September 18, 2026.
An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.
0.68

The 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)".

Start: May 12, 202390% CONFIDENCEfrom the source

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

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.

The FDA approved Veozah (fezolinetant) on 12 May 2023 for moderate to severe hot flashes caused by menopause^[1][2]
It is the first neurokinin 3 (NK3) receptor antagonist approved for menopausal hot flashes, and it is not a hormone, so it is an option for women who cannot take hormone therapy^[1]
Hot flashes affect around 80% of menopausal women, according to the FDA^[1]
The label carried a warning for elevated liver enzymes, requiring blood tests before treatment and every three months for the first nine months^[1]
The application had Priority Review, and the approval went to Astellas Pharma US^[1][5]

Notable features

One 45 mg tablet once a day, with or without food^[1]
Blocks the NK3 receptor, which plays a role in the brain's regulation of body temperature^[1][3]
Efficacy shown in the 12-week placebo-controlled parts of two phase 3 trials, each running 52 weeks in total, with an average participant age of 54^[1]
Not for use with CYP1A2 inhibitors or in people with cirrhosis or severe kidney disease^[1]

@HealthDesk

References 590% CONFIDENCE

The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.

[1]90%
fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause
fda.gov· Posted Sep 25, 2026· Starts May 12, 2023 ✓· 48% of score
The FDA^[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)".
[2]90%
Novel Drug Approvals for 2023 (FDA)
fda.gov· Added Sep 25, 2026· 48% of score
FDA's^[1][3] 2023 list gives Veozah (fezolinetant) an approval date of 5/12/2023, to treat moderate to severe hot flashes caused by menopause.
[3]80%
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant)
fda.gov· Published Sep 12, 2024· 3% of score
Later FDA^[1][2] safety communication describing Veozah as a nonhormonal medicine approved in May 2023 that blocks the NK3 receptor in the brain's temperature control centre.
[4]70%
FDA approves Veozah, new drug to battle menopausal hot flashes (WKYC Channel 3)
youtube.com· Published May 16, 2023· 0% of score
Local TV report on the approval with a patient whose hot flashes began at 50.^[1]
[5]90%
Astellas' VEOZAH (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
newsroom.astellas.com· Published May 13, 2023· 0% of score
Astellas' release: the FDA^[1][2][3] approved Veozah 45 mg once daily on May 12; it is the first nonhormonal NK3 receptor antagonist for VMS, backed by the BRIGHT SKY programme (SKYLIGHT 1, 2 and 4) of over 3,000 people.

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Health09/25/2026@HealthDesk
FDA Approves Bayer's Lynkuet, a Dual NK1/NK3 Hot-Flash Pill
BayerMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 10/24/2025 5:25PMCONFIRMED 87% CONFIDENCE336 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.
0.82
Health09/25/2026@HealthDesk
FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 12/16/2024CONFIRMED 87% CONFIDENCE1.8 years agoThe FDA^[1][5] drug safety communication carries the entry "12-16-2024 Update: FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury".
The FDA adds a boxed warning, its most prominent, to Astellas' hot-flash pill Veozah after a patient suffered serious liver injury within about 40 days of starting it, and orders monthly liver tests for the first months.
0.75
Health09/25/2026@HealthDesk
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Sage TherapeuticsMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 08/04/2023CONFIRMED 89% CONFIDENCE3.1 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.
0.73
Health09/25/2026@HealthDesk
FDA Approves Opill, the First US Birth Control Pill Without a Prescription
PerrigoMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 07/13/2023CONFIRMED 90% CONFIDENCE3.2 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.
0.72
Health09/20/2026@TechDesk
Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA
Eli LillyIndianapolis, Indiana
Starts 04/01/2026CONFIRMED 85% CONFIDENCE177 days agoLilly^[3] and the FDA^[4] approval letter date the approval April 1, 2026.
The FDA approved Eli Lilly's Foundayo, a once-daily GLP-1 pill for weight loss that needs no food or water restrictions, with direct-to-consumer sales from April 6.
0.72
Health09/25/2026@HealthDesk
FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning
U.S. Food and Drug AdministrationMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 02/12/2026CONFIRMED 84% CONFIDENCE225 days agoThe FDA^[1][4] news release is headed "For Immediate Release: February 12, 2026" and says the FDA "has approved drug labeling changes to six menopausal hormone therapy products".
The FDA approves new labels for six menopausal hormone therapy products, one from each class, that drop the cardiovascular, breast cancer and dementia statements from the boxed warning; 29 companies have filed changes.
0.70
Health09/25/2026@HealthDesk
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
RocheMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 11/30/2026SCHEDULED 78% CONFIDENCEin 66 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.
0.70
Health09/23/2026@HealthDesk
Lilly Submits Retatrutide to the FDA for Approval
Eli LillyEli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United States
Starts 03/31/2027ESTIMATED3 months late77% CONFIDENCEin 187 daysLilly "plans to subsequently submit retatrutide in Q1 2027 for U.S. approval" - no day is given, so the pin takes the last day of the first quarter of 2027.^[1]
Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.
0.69
Health09/23/2026@HealthDesk
FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis
Johnson & JohnsonSpring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United States
Starts 03/17/2026 8:12PMCONFIRMED 88% CONFIDENCE192 days agoThe FDA's^[4] approval letter for NDA 220149 says the application "is approved, effective on the date of this letter" and was electronically signed "03/17/2026 04:12:23 PM" (Eastern, 20:12 UTC); J&J announced it the next morning: "SPRING HOUSE, Pa. (March 18, 2026) - ... announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE".
The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.
0.68
Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
Starts 07/24/2028ESTIMATED 50% CONFIDENCEin 1.8 yearsClinicalTrials.gov^[1] lists 2028-07-24 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Roche's phase 3 trial of Enicepatide in obesity or overweight reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,000 participants. The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
0.68
Health09/25/2026@HealthDesk
FDA Approves Evita Solutions' Generic Mifepristone
Evita SolutionsMahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United States
Starts 09/30/2025 2:20PMCONFIRMED 83% CONFIDENCE360 days agoThe ANDA 216616 approval letter says "the ANDA is approved, effective on the date of this letter" and is digitally signed "Date: 9/30/2025 10:20:02AM".^[1]
The FDA approved Evita Solutions' 200 mg mifepristone tablets as the second generic of the abortion pill, less than two weeks after HHS promised a safety review of the drug.
0.68
Health09/23/2026@HealthDesk
FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer
Eli LillyBowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United States
Starts 09/18/2026CONFIRMED 85% CONFIDENCE7 days agoLilly's release is datelined "INDIANAPOLIS, Sept. 18, 2026" and says it "announced today that the U.S. Food and Drug Administration (FDA^[4]) has granted full approval"; the FDA's own notice gives the approval date as September 18, 2026.
An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.
0.68

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