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

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

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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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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Health09/30/2026@ThePinGang
FDA Decision Date for ImmunityBio's Anktiva in Papillary Bladder Cancer
FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United StatesImmunityBio
Starts 01/06/2027SCHEDULEDDate 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 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 98 daysImmunityBio's^[1][2] release says the FDA "assigned a PDUFA target action date of January 6, 2027" for the supplemental BLA.
The FDA has assigned a 6 January 2027 PDUFA target date for ImmunityBio's supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.
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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 12/16/2024CONFIRMEDDate 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 better1.8 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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Law09/25/2026@LawDesk
Supreme 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
Starts 05/14/2026CONFIRMEDDate confidence: CONFIRMEDStated as firmHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all CONFIRMED pins84% CONFIDENCEOverall confidence: 84%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 better139 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.
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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 03/31/2027ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins3 months late77% CONFIDENCEOverall confidence: 77%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 182 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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Health09/30/2026@ThePinGang
Generic Lenacapavir HIV Prevention Shot Expected on Market by End-2026
Geneva, SwitzerlandThe Global Fund
Starts 12/31/2026ESTIMATEDDate confidence: ESTIMATEDA target, not a fixed dateHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all ESTIMATED pins70% CONFIDENCEOverall confidence: 70%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 from 50% to 74% confidencein 92 daysThe Global Fund^[1][3] writes "Generic lenacapavir is expected to enter the market by the end of 2026", giving no day, so the pin takes 31 December.
The Global Fund expects generic lenacapavir, the twice-yearly HIV prevention injection, to enter the market by the end of 2026, with 24 countries worldwide due to receive it by then. Nearly 100,000 people in nine high-burden African countries had received it by mid-August 2026.
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Health09/23/2026@HealthDesk
Senate HELP Committee Holds Heidi Overton's FDA Commissioner Hearing
430 Dirksen Senate Office Building, Washington, D.C.U.S. Food and Drug Administration
Starts 09/24/2026 2:30PMSCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins85% CONFIDENCEOverall confidence: 85%How well the pin's source and references back up its dates.Weighted average of how firmly 6 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 better6 days agoGiven as scheduled, per help.senate.gov^[1][3]: "Date: Thursday, September 24, 2026 / Time: 10:30 AM ET/ 9:30 AM CT / Location: 430 Dirksen Senate Office Building"; it takes place "directly after the HELP Committee votes" on other nominations, so it may start a little later.
The Senate HELP Committee questions Dr. Heidi Overton, President Trump's pick for FDA commissioner, at 10:30 a.m. ET in 430 Dirksen. If confirmed, the White House domestic policy aide would take over an agency that has lost more than 3,000 staff in the past year.
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Health09/30/2026@ThePinGang
FDA Vaccine Advisers Meet on 2027 Southern Hemisphere Flu Strains
FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United StatesU.S. Food and Drug Administration
Starts 10/01/2026 1:00PMSCHEDULEDDate 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 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 1 dayFDA's^[1][2] meeting notice lists October 1, 2026, 9:00 a.m. - 1:00 p.m. ET and says the Committee "will convene in open session to discuss strain selection for influenza virus vaccines for the 2027 Southern Hemisphere influenza season".
FDA's Vaccines and Related Biological Products Advisory Committee meets virtually, 9:00 a.m. to 1:00 p.m. ET, to recommend influenza strains for the 2027 Southern Hemisphere vaccines, with a public FDA webcast.
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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 08/30/2028ESTIMATEDDate 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 1.9 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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Health09/20/2026@HealthDesk
Enicepatide's Phase 3 Trial in Obesity or Overweight Reads Out
RocheBasel, Canton of Basel-Stadt, Switzerland
Starts 07/24/2028ESTIMATEDDate 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 1.8 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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Law09/23/2026@LawDesk
Google and DOJ Due to File a Joint Proposed Final Judgment in Ad Tech Case
Albert V. Bryan United States Courthouse, 401 Courthouse Square, Alexandria, VA 22314, United StatesGoogle
Starts 10/02/2026SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins86% CONFIDENCEOverall confidence: 86%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 betterin 2 daysThe court's 2 September 2026 order (ECF 1857) directs the parties to "file one jointly proposed Final Judgment" "within 30 days of the date of this Order", which falls on 2 October 2026, and AdExchanger^[1] reports "Both parties have until October 2 to submit their proposed final judgments".
Google and the Justice Department must file one jointly proposed Final Judgment in the ad tech antitrust case by 2 October 2026, writing Judge Brinkema's behavioral remedies into an order that takes effect 60 days after she enters it.
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