Law09/25/2026@LawDesk
Fifth Circuit Reinstates In-Person Dispensing for Mifepristone
United States Court of Appeals for the Fifth CircuitUnited States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United States
Starts 05/01/2026CONFIRMED 82% 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.
0.73
Law09/25/2026@LawDesk
Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
Starts 05/14/2026CONFIRMED 84% 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.
0.71
Law09/25/2026@LawDesk
Fifth Circuit Hears Louisiana's Appeal Against Mail-Order Mifepristone
United States Court of Appeals for the Fifth CircuitUnited States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United States
Starts 09/09/2026CONFIRMED 83% 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.
0.68
Law09/25/2026@LawDesk
Supreme Court Rejects Challenge to Mifepristone in FDA v. Alliance
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
Starts 06/13/2024CONFIRMED 84% CONFIDENCE2.3 years agoThe slip opinion in No. 23-235 is headed "Argued March 26, 2024—Decided June 13, 2024".^[1]
A unanimous Supreme Court threw out anti-abortion doctors' challenge to the FDA's rules for the abortion pill mifepristone, holding they had no standing to sue, so mail and telehealth access stayed in place.
0.67
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.
0.67
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.
0.67
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.
0.67
Health09/25/2026@HealthDesk
FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 05/12/2023CONFIRMED 90% 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.
0.66
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.
0.66
Health09/23/2026@HealthDesk
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 09/08/2026CONFIRMED 86% 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.
0.65
Health09/23/2026@HealthDesk
FDA Approves Abbott's Volt PFA System for AFib
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 12/22/2025CONFIRMED 84% 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.
0.65
Health09/23/2026@HealthDesk
Lilly Presents eloraTZP Phase 2 Results at EASD 2026 in Milan
Allianz MiCo, Via Demetrio Stratos, Bolla, Milan, Lombardy 20149, ItalyEli Lilly
Starts 09/30/2026 2:30PMSCHEDULED 86% CONFIDENCEin 5 daysLilly's release lists "EloraTZP symposium | Wednesday, September 30, 2026 | 4:30 to 5:30 p.m. CEST", and the EASD^[2] 2026 Final Programme puts the session at 16:30 - 17:30 on Wednesday 30 September in Budapest Hall.
First Phase 2 results for eloraTZP - Lilly's once-weekly amylin drug eloralintide combined with tirzepatide (Mounjaro, Zepbound) - in adults with obesity or overweight and type 2 diabetes, unveiled at an EASD symposium on amylin in Milan.
0.65

The 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]

Start: Sep 30, 202590% CONFIDENCEfrom the source

FDA Approves Evita Solutions' Generic Mifepristone

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.

The FDA approved Evita Solutions' abbreviated new drug application 216616 for mifepristone tablets, 200 mg, finding them bioequivalent and therapeutically equivalent to Danco's Mifeprex^[1]
Evita's product joins the single shared Mifepristone REMS Program, the safety programme covering mifepristone with misoprostol through 70 days' gestation^[1]
The application had been under review since 1 October 2021^[1]
It is the second generic after GenBioPro's in 2019; the FDA issued no press release, and Evita said the product would be available in January 2026^[4]
The approval came less than two weeks after HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary told Republican attorneys general the agency would review the drug's safety, and anti-abortion groups condemned it^[3][4]
That review, covering the 2023 rules that allow mail dispensing, is the one Louisiana's lawsuit later leaned on^[2]

Notable features

Mifepristone 200 mg tablet, a progesterone blocker taken with misoprostol for medication abortion^[1]
Generic of Mifeprex (NDA 020687), dispensed only under the Mifepristone REMS Program's certified prescriber and pharmacy rules^[1]

@HealthDesk

References 483% 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%
accessdata.fda.gov/drugsatfda_docs/appletter/2025/216616s000ltr.pdf
accessdata.fda.gov· Posted Sep 25, 2026· Starts Sep 30, 2025 ✓· 48% of score
The 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".
[2]75%
Louisiana v. FDA: Access to Mifepristone Back at the Supreme Court (KFF)
kff.org· Published May 6, 2026· 28% of score
Names Danco, GenBioPro and Evita Solutions as the three mifepristone makers, and quotes FDA's^[1] September 2025 review announcement citing the "lack of adequate consideration underlying the prior REMS approvals".
[3]75%
FDA approves new, generic form of abortion pill (ABC News)
youtube.com· Published Oct 3, 2025· 12% of score
ABC News: the FDA^[1] approved a second generic version of mifepristone as Health Secretary Robert F. Kennedy Jr. pledged to investigate abortion medication.
[4]85%
FDA quietly approved a generic abortion pill ahead of shutdown (NBC News)
nbcnews.com· Published Oct 2, 2025· 12% of score
Reports the Tuesday approval, that Evita's is the second generic after GenBioPro's in 2019, that Evita expected the product in January 2026, and that it came less than two weeks after Kennedy and Makary told state attorneys general the FDA^[1] would review mifepristone's safety.

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Law09/25/2026@LawDesk
Fifth Circuit Reinstates In-Person Dispensing for Mifepristone
United States Court of Appeals for the Fifth CircuitUnited States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United States
Starts 05/01/2026CONFIRMED 82% 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.
0.73
Law09/25/2026@LawDesk
Supreme Court Restores Mail Access to Mifepristone in Louisiana Case
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
Starts 05/14/2026CONFIRMED 84% 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.
0.71
Law09/25/2026@LawDesk
Fifth Circuit Hears Louisiana's Appeal Against Mail-Order Mifepristone
United States Court of Appeals for the Fifth CircuitUnited States Court of Appeals Fifth Circuit, 600, Camp Street, Central Business District, French Quarter, New Orleans, Orleans Parish, Louisiana, 70130, United States
Starts 09/09/2026CONFIRMED 83% 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.
0.68
Law09/25/2026@LawDesk
Supreme Court Rejects Challenge to Mifepristone in FDA v. Alliance
Supreme Court of the United StatesSupreme Court of the United States, 1, 1st Street Northeast, Ward 6, Washington, District of Columbia, 20543, United States
Starts 06/13/2024CONFIRMED 84% CONFIDENCE2.3 years agoThe slip opinion in No. 23-235 is headed "Argued March 26, 2024—Decided June 13, 2024".^[1]
A unanimous Supreme Court threw out anti-abortion doctors' challenge to the FDA's rules for the abortion pill mifepristone, holding they had no standing to sue, so mail and telehealth access stayed in place.
0.67
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.
0.67
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.
0.67
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.
0.67
Health09/25/2026@HealthDesk
FDA Approves Veozah, the First Non-Hormonal NK3 Pill for Hot Flashes
Astellas PharmaMahan Court, FDA White Oak Campus, White Oak, Montgomery County, Maryland, 20993, United States
Starts 05/12/2023CONFIRMED 90% 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.
0.66
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.
0.66
Health09/23/2026@HealthDesk
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 09/08/2026CONFIRMED 86% 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.
0.65
Health09/23/2026@HealthDesk
FDA Approves Abbott's Volt PFA System for AFib
Abbott LaboratoriesAbbott Labs, 100, Abbott Park Road, Illinois, 60064, United States
Starts 12/22/2025CONFIRMED 84% 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.
0.65
Health09/23/2026@HealthDesk
Lilly Presents eloraTZP Phase 2 Results at EASD 2026 in Milan
Allianz MiCo, Via Demetrio Stratos, Bolla, Milan, Lombardy 20149, ItalyEli Lilly
Starts 09/30/2026 2:30PMSCHEDULED 86% CONFIDENCEin 5 daysLilly's release lists "EloraTZP symposium | Wednesday, September 30, 2026 | 4:30 to 5:30 p.m. CEST", and the EASD^[2] 2026 Final Programme puts the session at 16:30 - 17:30 on Wednesday 30 September in Budapest Hall.
First Phase 2 results for eloraTZP - Lilly's once-weekly amylin drug eloralintide combined with tirzepatide (Mounjaro, Zepbound) - in adults with obesity or overweight and type 2 diabetes, unveiled at an EASD symposium on amylin in Milan.
0.65

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