FDA Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah

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• Health09/25/2026@HealthDesk

  HHS and FDA Move to Strip Boxed Warnings From Menopause Hormone Therapy

  U.S. Department of Health and Human Services, 200, Independence Avenue Southwest, Ward 6, Washington, District of Columbia, 20201, United StatesU.S. Food and Drug Administration

  

  Starts 11/10/2025 4:09PMCONFIRMED86% CONFIDENCE319 days agoThe FDA^[1][3] news release is headed "For Immediate Release: November 10, 2025" and says Kennedy and Makary "made the announcement at a press conference at HHS"; CBS News' livestream of it began at 16:09 UTC.

  At an HHS press conference, Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announce that the FDA will remove the breast cancer, heart disease and dementia boxed warnings that have covered menopausal hormone therapy since the early 2000s.

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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 05/12/2023CONFIRMED90% CONFIDENCE3.4 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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• Health09/25/2026@HealthDesk

  FDA Approves First HRT Labels Without the Breast Cancer Boxed Warning

  Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesU.S. Food and Drug Administration

  

  Starts 02/12/2026CONFIRMED84% 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

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

  

  Starts 11/30/2026SCHEDULED78% 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.

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• 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 5:25PMCONFIRMED87% 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.

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• Health09/23/2026@HealthDesk

  Lilly Submits Retatrutide to the FDA for Approval

  Eli Lilly and Company Corporate Center, East McCarty Street, Indianapolis, Indiana 46206, United StatesEli Lilly

  

  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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• Health09/25/2026@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 08/04/2023CONFIRMED89% 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.

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• Law09/25/2026@LawDesk

  Fifth Circuit Reinstates In-Person Dispensing for Mifepristone

  United States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United StatesUnited States Court of Appeals for the Fifth Circuit

  

  Starts 05/01/2026CONFIRMED82% CONFIDENCE147 days agoThe opinion in No. 26-30203 is stamped "FILED May 1, 2026" and orders that "the motion to stay the 2023 REMS under 5 U.S.C. § 705 pending appeal is GRANTED".^[1]

  A Fifth Circuit panel granted Louisiana a stay of the FDA's 2023 mifepristone rules, ending telehealth prescribing and mail or pharmacy dispensing of the abortion pill nationwide until the Supreme Court stepped in.

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• Health09/20/2026@HealthDesk

  Maridebart Cafraglutide's Phase 3 Trial in Heart Failure With Preserved Ejection Fraction Reads Out

  AmgenThousand Oaks, United States

  Starts 06/30/2028ESTIMATED50% CONFIDENCEin 1.8 yearsClinicalTrials.gov^[1] lists 2028-06-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Amgen's phase 3 trial of Maridebart Cafraglutide in heart failure with preserved ejection fraction reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,056 participants. This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

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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

  Starts 07/24/2028ESTIMATED50% 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.

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• Health09/20/2026@HealthDesk

  BI 690517's Phase 3 Trial in Kidney Disease, Chronic Reads Out

  Boehringer IngelheimIngelheim am Rhein, Mainz-Bingen district, Germany

  Starts 08/30/2028ESTIMATED50% CONFIDENCEin 1.9 yearsClinicalTrials.gov^[1] lists 2028-08-30 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Boehringer Ingelheim's phase 3 trial of BI 690517 in kidney disease, chronic reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 11,000 participants. This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation.

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• Health09/25/2026@HealthDesk

  FDA Approves Evita Solutions' Generic Mifepristone

  Mahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United StatesEvita Solutions

  

  Starts 09/30/2025 2:20PMCONFIRMED83% 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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