FDA Decision Date for ImmunityBio's Anktiva in Papillary Bladder Cancer

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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 11/30/2026SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins78% CONFIDENCEOverall confidence: 78%How well the pin's source and references back up its dates.Weighted average of how firmly 4 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or betterin 61 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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• Health09/30/2026@ThePinGang

  FDA Decision Due on GSK's Bepirovirsen for Chronic Hepatitis B

  FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United StatesGSK

  

  Starts 10/26/2026SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins75% CONFIDENCEOverall confidence: 75%How well the pin's source and references back up its dates.Weighted average of how firmly 3 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or betterin 26 daysGSK's^[1][2] release states "October 26, 2026 assigned by FDA as PDUFA date" and its later release says a US decision is "expected from the FDA by 26 October 2026".

  The FDA has set 26 October 2026 as its priority-review goal date for GSK's bepirovirsen, an antisense drug aimed at a functional cure of chronic hepatitis B after two positive phase III B-Well trials.

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• Health09/23/2026@HealthDesk

  FDA Approves Lilly's Inluriyo With Verzenio for ESR1-Mutated Breast Cancer

  Bowditch Road, Federal Research Center, Hillandale, Montgomery County, Maryland, 20993, United StatesEli Lilly

  

  Starts 09/18/2026CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins85% CONFIDENCEOverall confidence: 85%How well the pin's source and references back up its dates.Weighted average of how firmly 5 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better12 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.

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• Health09/20/2026@HealthDesk

  PCV21 Vaccine's Phase 3 Trial in Pneumococcal Immunization Reads Out

  SanofiParis, Grand Paris, France

  Starts 06/07/2027ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidencein 250 daysClinicalTrials.gov^[1] lists 2027-06-07 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Sanofi's phase 3 trial of PCV21 Vaccine in pneumococcal immunization reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,195 participants. This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age.

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• Health09/20/2026@HealthDesk

  MenQuadfi's Phase 3 Trial in Meningococcal Infection Reads Out

  SanofiParis, Grand Paris, France

  Starts 03/13/2028ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidencein 1.5 yearsClinicalTrials.gov^[1] lists 2028-03-13 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Sanofi's phase 3 trial of MenQuadfi in meningococcal infection reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 4,568 participants. The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China. Study details include: * Study duration (including 6-month safety follow-up after the last dose): * Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months) * Cohort II (Groups 3 and 4): up to 18 months * Cohort III (Groups 5 and 6): up to 21 months * Cohort III (Group 7): approximately 16 months * Vaccination Visits Period: * Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121).

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• Health09/20/2026@HealthDesk

  Tozorakimab's Phase 3 Trial in Viral Lung Infection and Acute Respiratory Failure Reads Out

  AstraZenecaCambridge, United Kingdom

  Starts 11/04/2027ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidencein 1.1 yearsClinicalTrials.gov^[1] lists 2027-11-04 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  AstraZeneca's phase 3 trial of Tozorakimab in viral lung infection and acute respiratory failure reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 3,527 participants. The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

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• Health09/20/2026@HealthDesk

  MK-8527's Phase 3 Trial in Human Immunodeficiency Virus Reads Out

  Merck & Co.Rahway, United States

  Starts 10/18/2027ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidencein 1.1 yearsClinicalTrials.gov^[1] lists 2027-10-18 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Merck & Co.'s phase 3 trial of MK-8527 in human immunodeficiency virus reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 4,580 participants. Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.

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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 05/01/2026CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins82% CONFIDENCEOverall confidence: 82%How well the pin's source and references back up its dates.Weighted average of how firmly 5 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better152 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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• Health09/23/2026@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 8:12PMCONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins88% CONFIDENCEOverall confidence: 88%How well the pin's source and references back up its dates.Weighted average of how firmly 4 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better197 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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• Health09/23/2026@HealthDesk

  FDA Authorizes Abbott's Libre Duo Glucose-Ketone Sensor

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

  

  Starts 08/25/2026CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins87% CONFIDENCEOverall confidence: 87%How well the pin's source and references back up its dates.Weighted average of how firmly 5 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better36 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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• Health09/20/2026@HealthDesk

  Camizestrant's Phase 3 Trial in Breast Cancer, Early Breast Cancer Reads Out

  AstraZenecaCambridge, United Kingdom

  Starts 04/20/2027ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidencein 202 daysClinicalTrials.gov^[1] lists 2027-04-20 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  AstraZeneca's phase 3 trial of Camizestrant in breast cancer, early breast cancer reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 4,300 participants. This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

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• Health09/20/2026@HealthDesk

  C.Difficile Vaccine's Phase 3 Trial in Clostridoides Difficile Associated Disease Reads Out

  PfizerNew York City, New York, United States

  Starts 12/11/2028ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins50% CONFIDENCEOverall confidence: 50%How well the pin's source and references back up its dates.Weighted average of how firmly 1 reference, the source included, supports the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins from 50% to 74% confidencein 2.2 yearsClinicalTrials.gov^[1] lists 2028-12-11 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.

  Pfizer's phase 3 trial of C.Difficile Vaccine in clostridoides difficile associated disease reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 32,500 participants. The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle. This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly does not work. Participants will stay in the study until enough events have occurred to answer the main question.

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