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FDA Approves Abbott's TactiFlex Duo Ablation Catheter
CONFIRMED86% CONFIDENCE17 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.0.64Fifth 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
CONFIRMED82% 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.0.62FDA Approves Evita Solutions' Generic Mifepristone
Mahan Court, Federal Research Center, White Oak, Montgomery County, Maryland, 20993, United StatesEvita Solutions
CONFIRMED83% 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.0.62FDA 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
CONFIRMED84% 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.0.62FDA Approves Abbott's Volt PFA System for AFib
CONFIRMED84% CONFIDENCE277 days agoThe release is datelined "ABBOTT PARK, Ill., Dec. 22, 2025" and says Abbott "today announced" the FDA[5] has approved the Volt PFA System (the FDA's own record gives a decision date of 12/19/2025).The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.0.60FDA Approves Zurzuvae, the First Pill for Postpartum Depression
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesSage Therapeutics
CONFIRMED89% 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.0.60FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
Mahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United StatesRoche
SCHEDULED78% 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.0.60Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United StatesSupreme Court of the United States
CONFIRMED84% CONFIDENCE134 days agoThe order in Nos. 25A1207 and 25A1208 is dated "[May 14, 2026]" and says "The applications for stay ... are granted".[1]The Supreme Court stayed the Fifth Circuit's order in Louisiana v. FDA, so mifepristone can again be prescribed by telehealth and sent by mail while the case goes on; Justices Thomas and Alito dissented.0.60FDA Approves Icotyde, the First Oral IL-23 Receptor Pill for Psoriasis
Spring House, Lower Gwynedd Township, Montgomery County, Pennsylvania, 19477, United StatesJohnson & Johnson
CONFIRMED88% 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.0.59Fifth Circuit Hears Louisiana's Appeal Against Mail-Order 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
CONFIRMED83% CONFIDENCE16 days agoThe court's recording of 26-30203 State of Louisiana v. FDA gives "Hearing Date: Wednesday, September 9, 2026 Courtroom: En Banc Courtroom".[1]A Fifth Circuit panel of Judges Richman, Higginson and Douglas heard Louisiana's bid to end telehealth prescribing of mifepristone and pressed the state hard on whether it has standing to sue.0.59FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor
CONFIRMED87% CONFIDENCE31 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.0.59FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer
Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United StatesEli Lilly
CONFIRMED85% 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.0.59
