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

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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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• Health09/23/2026@HealthDesk

  FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor

  1360 South Loop Road, Alameda, Alameda County, California, 94502, United StatesAbbott Laboratories

  

  Starts 08/25/2026CONFIRMED87% CONFIDENCE32 days agoThe release is datelined "ABBOTT PARK, Ill., Aug. 25, 2026" and says Abbott "today announced U.S. Food and Drug Administration (FDA^[2][3]) authorization of its Libre Duo 10 Day system"; the FDA's De Novo record gives the same decision date, 08/25/2026.

  The FDA authorized Abbott's Libre Duo 10 Day, the first wearable to continuously track both glucose and ketones, which alerts people with diabetes aged 2 and older to rising ketones before diabetic ketoacidosis.

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• Health09/23/2026@HealthDesk

  FDA Approves Abbott's TactiFlex Duo Ablation Catheter

  Abbott Labs, 100, Abbott Park Road, Illinois, 60064, United StatesAbbott Laboratories

  

  Starts 09/08/2026CONFIRMED86% CONFIDENCE18 days agoThe release is datelined "ABBOTT PARK, Ill., Sept. 8, 2026" and says Abbott "announced today it has received U.S. Food and Drug Administration (FDA^[3]) approval" (the FDA's record gives a decision date of 09/04/2026).

  The FDA approved Abbott's TactiFlex Duo, a catheter that can deliver pulsed field ablation, radiofrequency energy or both in one procedure to treat complex atrial fibrillation. The approval rested on the FlexPulse IDE study.

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• Health09/20/2026@TechDesk

  Lilly's Foundayo (Orforglipron) Weight-Loss Pill Approved by FDA

  Indianapolis, IndianaEli Lilly

  

  Starts 04/01/2026CONFIRMED85% CONFIDENCE178 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 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 65 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 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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• Health09/23/2026@HealthDesk

  FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis

  Spring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United StatesJohnson & Johnson

  

  Starts 03/17/2026 8:12PMCONFIRMED88% CONFIDENCE193 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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• Health09/25/2026@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% CONFIDENCE361 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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• Health09/25/2026@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 07/13/2023CONFIRMED90% 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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• Health09/23/2026@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 186 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 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% CONFIDENCE226 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 Puts a Boxed Liver-Injury Warning on Menopause Drug Veozah

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

  

  Starts 12/16/2024CONFIRMED87% 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.

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