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https://www.statnews.com/2026/03/12/epstein-friend-attempts-biotech-comeback-prasad-exits-fda-readout-loud/ Epstein pal attempts a biotech comeback and Vinay Prasad exits FDA | STAT Mar 12, 2026 - On this week's The Readout LOUD, the hosts also recap Novo Nordisk and Hims' detente and Xenon Pharmaceuticals' promising seizure data. vinay prasad fda stat epstein pal attempts https://www.statnews.com/2025/07/19/epcc-report-mifepristone-abortion-pill-republican-politicians-fda-undermining-biotech/ Conservative politicians using flawed abortion-pill report to attack FDA | STAT A politically motivated, deeply flawed report on mifepristone is shaping policy, political strategy, and public discourse, writes biotech exec. abortion pill fda stat conservative politicians using https://www.statnews.com/2026/02/26/rare-disease-treatment-approval-fda-mixed-messages/ Rare disease advocates perplexed by mixed messages at the FDA | STAT Feb 26, 2026 - FDA has rejected or reversed course on five gene therapies for rare diseases while simultaneously unveiling expedited pathways for new treatment approvals. rare disease mixed messages fda stat advocates perplexed https://reports.statnews.com/collections/all-reports/products/failed-trial-successful-drug Failed trial, successful drug: How a negative readout can lead to FDA | STAT Reports In this STAT Report author Frank David, M.D., Ph.D., explores the question, how can you tell if there’s still hope a drug will be approved when a pivotal trial... successful drug fda stat failed trial negative https://www.statnews.com/2026/04/15/peptides-fda-panel-to-discuss-broader-access-compounding/ FDA peptide advisers expected to support RFK Jr.'s legalization push | STAT Apr 15, 2026 - Legal peptides draw closer: Kennedy schedules FDA advisory meeting for July, and he gets to appoint the experts who will consider reversing a Biden-era ban. rfk jr fda peptide advisers expected https://www.statnews.com/2025/05/20/fda-vaccine-framework-new-covid-shot-recommendations-vinay-prasad-marty-makary/ FDA vaccine framework changes Covid shot recommendations | STAT May 20, 2025 - FDA leaders said recommending universal vaccination against Covid-19 is out of step with the rest of the world and may no longer be needed fda vaccine covid shot framework changes recommendations https://www.statnews.com/2026/02/05/corcept-therapeutics-fda-relacorilant-cushings-disease/ A dispute between Corcept Therapeutics, FDA runs deep | STAT Feb 5, 2026 - Concerns over a potential risk of liver injury induced by the company's treatment, relacorilant, raise doubts. corcept therapeutics runs deep dispute fda stat https://www.statnews.com/2026/03/09/fda-cuts-back-advisory-meetings-controversial-decisions-grow/ FDA advisory committee meetings fade as controversial decisions grow | STAT Mar 9, 2026 - Controversial drug decisions mount as FDA reduces public advisory meetings. Industry leaders say the adcomms can add transparency to the approval process. advisory committee meetings fda fade controversial decisions https://www.statnews.com/pharmalot/2026/03/26/fda-rare-disease-pto-novo-nordisk-340b-abortion-hiv/ Pharmalittle: FDA approves rare disease drug, PTO chief grilled | STAT Mar 26, 2026 - A bipartisan quartet of senators unveiled legislation to cap the monthly cost of insulin at $35 for patients on private insurance. rare disease drug pharmalittle fda approves pto chief https://www.statnews.com/2026/04/24/trump-psychedelic-drugs-fda-priority-review-mental-health-treatment/ FDA fast-tracks review of new psychedelic mental health treatments | STAT Apr 24, 2026 - After Trump administration prodding, FDA offers priority review of psychedelic drugs from Compass Pathways, Usona Institute, and Transcend Therapeutics. fda fast tracks mental health treatments review new psychedelic https://reports.statnews.com/collections/all-reports/products/inside-the-fda-under-trump Chaotic and politicized: Inside the FDA under Trump | STAT Report | STAT Reports Layoffs, leadership chaos, and politicized science have destabilized the FDA under Trump. This STAT Special Report explains what happened, why it matters, and... stat report reports chaotic politicized inside fda https://www.statnews.com/pharmalot/2026/03/27/novo-nordisk-boost-consumer-focus-fda-approves-gene-therapy/ Pharmalittle: Novo boosts consumer focus, FDA okays gene therapy | STAT Mar 27, 2026 - People with pre-existing depression or anxiety were less likely to have worsening mental health while taking a GLP-1 medication. gene therapy pharmalittle novo boosts consumer https://www.statnews.com/2026/02/23/harrisonai-fda-petition-exempt-ai-devices-premarket-review/ Petition pushes FDA to exempt AI devices from premarket review | STAT A petition from Harrison.ai asks the FDA to exempt some new AI tools radiologists use to analyze medical images from routine premarket review. ai devices petition pushes fda exempt https://www.statnews.com/2025/05/22/fda-commissioner-marty-makary-senate-testimony-drug-approvals-job-cuts-covid-boosters/ FDA's Makary pushes back on criticism, explains Covid booster plan | STAT May 22, 2025 - Makary told senators that staffing cuts haven't hindered the FDA's main missions. pushes back covid booster fda makary criticism https://www.statnews.com/2025/12/10/fda-panel-ease-access-testosterone-therapy-men/ FDA panel urges easier access to testosterone therapy for men | STAT Dec 17, 2025 - One month after removing black box warning labels for estrogen therapy for menopause, FDA panel members urge easier access to testosterone for men. panel urges easier access testosterone therapy men stat fda https://www.statnews.com/2026/03/18/huntingtons-uniqure-fda-jnj-psoriasis-icotyde-readout-newsletter/ Readout newsletter: Huntington's researcher on UniQure-FDA fray | STAT Mar 18, 2026 - Today's biotech news includes Ed Wild, a longtime Huntington's clinician, treading lightly into the back and forth between UniQure and FDA. readout newsletter huntington researcher uniqure fda https://www.statnews.com/2026/02/23/fda-lobbying-trump-connected-firms-cash-in/ Pharma companies turn to Trump-connected firms for FDA lobbying | STAT Checkmate Government Relations, Miller Strategies, and Ballard Partners see a surge in business as pharma giants see new lobbying opportunities at the FDA. pharma companies turn trump connected firms https://www.statnews.com/2026/03/18/how-arpah-developing-fda-authorized-ai-tools-ai-prognosis/ AI Prognosis: How ARPA-H is developing FDA-authorized AI agents | STAT Mar 18, 2026 - In this edition of STAT's AI Prognosis: A closer look at how U.S. moonshot agency for health research, ARPA-H, is developing FDA-authorized AI agents. ai prognosis arpa h fda authorized developing agents https://www.statnews.com/2026/02/19/hims-super-bowl-ad-moderna-fda-readout-loud/ Readout LOUD podcast: Hims GLP-1 pill fallout, FDA and Moderna| STAT Feb 19, 2026 - Was Hims' Super Bowl ad the final straw for regulators? STAT's Katie Palmer joins the podcast this week to discuss. readout loud podcast glp 1 pill hims fallout fda https://www.statnews.com/pharmalot/2026/04/01/fda-compounding-peptides-iran-war-trial-recruitment/ Pharmalittle: FDA changing view on peptides; Iran war affects trials| STAT Apr 1, 2026 - Of more than 65,000 clinical trials recruiting patients in 186 countries, nearly 7% have been affected by the Iran war. iran war affects pharmalittle fda trials stat changing view https://www.statnews.com/pharmalot/2026/04/14/fda-push-clinical-trial-transparency-novo-nordisk-openai-deal/ Pharmalittle: FDA push for trial transparency, Novo-OpenAI deal | STAT Apr 14, 2026 - AstraZeneca to require hospitals and clinics participating in a U.S. drug discount program to submit claims data for dispensing its drugs pharmalittle fda trial transparency openai deal push novo https://www.statnews.com/2025/09/08/pig-organ-transplant-egenesis-revivicor-human-trials-fda/ FDA expands access to gene-edited pig organ transplants | STAT Sep 8, 2025 - Gene-edited pig organ transplants from eGenesis and Revivicor are making their way into more human patients. expands access gene edited organ transplants fda pig https://www.statnews.com/2026/01/26/fda-makary-prasad-crispr-gene-editing-concerns-baby-kj/ New FDA pathway for CRISPR treatments raises concerns | STAT Jan 26, 2026 - A new FDA pathway meant to enable one-time gene-editing cures is welcomed in theory but could, ethicists warn, become a Pandora's box. new fda raises concerns pathway crispr treatments https://www.statnews.com/2026/02/23/fda-rare-disease-new-guidelines-plausible-mechanism-pathway/ FDA unveils new pathway for rare disease treatments | STAT rare disease treatments unveils new fda pathway stat https://www.statnews.com/2026/04/07/trump-budget-fda-proposals-pharmaceutical-industry-dc-diagnosis/ Trump budget: FDA ideas to boost U.S. pharma manufacturing | STAT Apr 7, 2026 - Trump's 2027 budget proposals span health care, RFK Jr. set to appear before Congress, and more from STAT's D.C. Diagnosis. trump budget pharma manufacturing fda ideas boost https://www.statnews.com/2026/03/10/ron-johnson-investigating-fda-rare-disease-drug-denials/ GOP Sen. Johnson investigating FDA rare disease drug rejections | STAT Mar 10, 2026 - Sen. Ron Johnson has long been an advocate for giving people with rare diseases speedy access to experimental treatments. rare disease drug gop sen johnson investigating fda https://www.statnews.com/2026/03/31/baby-kj-gene-editing-fda-rules-pose-expansion-hurdle/ Baby KJ researchers face FDA hurdle on scaling custom treatments | STAT Mar 31, 2026 - After a baby treated by custom gene editing inspired a new FDA pathway, strict FDA manufacturing rules threaten to keep bespoke cures out of reach. baby kj treatments stat researchers face fda https://www.statnews.com/2026/03/10/fda-says-leucovorin-evidence-lacking-for-autism/ FDA approves leucovorin for rare disorder, not for autism | STAT Mar 10, 2026 - The FDA action represents a retreat from top officials’ earlier insistence that leucovorin could benefit fda approves rare disorder leucovorin autism stat https://www.statnews.com/2026/03/05/vinay-prasad-peter-marks-fda-regulatory-frameworks/ The extremism of the FDA's Marks and Prasad has come with costs | STAT Mar 5, 2026 - In this week's edition of costs stat extremism fda marks prasad https://www.statnews.com/2026/03/03/prime-medicine-seeks-fda-approval-cgd-disease-gene-editing-treatment/ Prime Medicine seeks FDA treatment approval after two-patient trial | STAT Mar 4, 2026 - Prime Medicine's application will test an FDA that has promised to speed new gene-editing treatments but has recently spurned some. prime medicine trial stat seeks fda treatment https://www.statnews.com/2026/02/05/super-bowl-ads-drug-companies-fda-rules/ Super Bowl ads highlight tension between FDA and drug companies | STAT FDA announced a crackdown on TV pharmaceutical advertising last fall. This week's STATus Report looks at which Super Bowl ads may be pushing the limits. super bowl ads drug companies highlight tension fda https://www.statnews.com/2025/05/20/fda-covid-vaccine-recommendations-future-plan-for-infants-worries-pediatricians/ Worried pediatricians question new FDA Covid vaccine guidance | STAT May 20, 2025 - FDA vaccine framework may one day drop current routine shots for infants. If vaccine is effective, it should be used, pediatricians argue question new fda covid vaccine guidance worried pediatricians https://www.statnews.com/2026/04/09/fda-rejects-proposal-to-deregulate-ai-devices-health-tech/ STAT Health Tech: FDA rejects proposal to deregulate AI devices Apr 9, 2026 - In this edition of STAT Health Tech: The FDA rejects a proposal to deregulate certain types of AI devices, Boehringer Ingelheim invests $50 million in DTx, and... stat health tech rejects proposal ai devices fda deregulate https://www.statnews.com/2026/04/13/vinay-prasad-replacement-fda-cber/ Prasad’s FDA successor faces an almost impossible challenge | STAT Lacking political savvy pretty much doomed Vinay Prasad at the FDA. His successor will have to make tough choices. almost impossible fda successor faces challenge https://www.statnews.com/2025/05/22/covid-vaccine-mrna-safety-effective-fda-framework-big-beautiful-bill-medicaid-cuts-taxes-dc-diagnosis-newsletter/ D.C. Diagnosis: House bill cuts Medicaid, FDA's new vaccine policy | STAT May 22, 2025 - This week in health care policy and politics: Dissecting the GOP's tax cut bill, how we know mRNA vaccines work, and more. c diagnosis house bill cuts medicaid new vaccine policy stat https://www.statnews.com/2026/04/02/fda-ai-breakthrough-medical-device-stat-health-tech/ STAT Health Tech: What counts as an AI 'breakthrough' device for the FDA? Apr 2, 2026 - In this edition of STAT Health Tech: Another study looked at benefits of AI scribes, and an analysis of AI-powered devices that got a 'breakthrough' label from... stat health tech ai breakthrough counts device fda https://www.statnews.com/pharmalot/2026/04/15/fda-seeks-data-lilly-obesity-pill-pharma-win-340b-case-hiv/ Pharmalittle: FDA seeks Lilly obesity pill data, pharma gets 340B win | STAT Apr 15, 2026 - A Delaware judge threw out lawsuits seeking to link the Zantac heartburn drug to cancer, freeing drugmakers from facing trials in the state. pharmalittle fda obesity pill seeks lilly data https://www.statnews.com/2025/11/06/fda-melodrama-pfizer-novo-metsera-readout-loud/ Readout LOUD podcast: FDA melodrama, Pfizer-Novo bidding war | STAT Nov 6, 2025 - There's a slow-boiling feud between FDA official Vinay Prasad and his staff, plus the shocking exit of CDER director George Tidmarsh. readout loud podcast bidding war fda melodrama pfizer https://www.statnews.com/2025/12/04/vinay-prasad-fda-defends-vaccine-plan-blames-false-narratives/ Embattled FDA official defends vaccine plan in closed-door remarks | STAT Dec 4, 2025 - Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence. official defends closed door embattled fda vaccine https://www.statnews.com/2026/03/27/fda-briefs-senators-food-safety-infant-formula-ultraprocessed-foods/ FDA briefs lawmakers on food safety priorities | STAT Mar 27, 2026 - The Trump administration's health agenda is increasingly focusing on food issues, an area that's popular with voters. food safety priorities stat fda briefs lawmakers https://www.statnews.com/2025/12/04/fda-tracy-beth-hoeg-psychedelics-future-readout-loud-podcast/ Readout LOUD podcast: A new FDA top drug regulator | STAT Dec 4, 2025 - The turmoil at the FDA continues: Richard Pazdur has announced his retirement, and he's being replaced by Covid contrarian Tracy Beth Høeg. readout loud podcast new fda top drug regulator stat https://www.statnews.com/2026/03/03/fda-breakthrough-designation-generative-ai-chatbot-recovryai/ FDA offers clues to AI regulation with RecovryAI designation | STAT A breakthrough designation for RecovryAI’s post-surgery chatbot offers clues to how FDA may regulate generative AI devices. offers clues ai regulation fda designation stat https://www.statnews.com/2026/01/14/medicare-automatic-coverage-medical-devices-fda-deems-breakthrough/ How much Medicare stands to pay for FDA breakthrough devices | STAT As Congress considers automatic Medicare coverage for 'breakthrough' devices, experts caution that it could drive up costs without improving patient outcomes. fda breakthrough much medicare stands pay https://www.statnews.com/2026/04/16/travere-therapeutics-kidney-disease-fda-approval/ Travere drug doesn’t improve kidney function. The FDA still approved it | STAT The agency has taken heat for not showing enough regulatory flexibility. In the case of Filspari, it showed too much. kidney function travere drug improve fda https://www.statnews.com/2026/02/19/fda-appoints-new-digital-health-center-director/ FDA taps AI executive to lead digital health center | STAT Feb 20, 2026 - The Food and Drug Administration has tapped a former executive from a health artificial intelligence company to lead its digital health center. digital health center taps ai fda executive lead https://www.statnews.com/2026/03/18/fda-nih-reduce-animal-testing-drug-development/ FDA and NIH push to reduce animal testing in drug development | STAT Mar 18, 2026 - FDA released guidance to help drug companies assess their products without animals. NIH will offer grants to find alternatives. reduce animal testing drug development fda nih push https://reports.statnews.com/collections/all-reports/products/speed-and-safety-fdas-drug-approval A guide to the FDA's drug approval pathways and processes | STAT Reports Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency... drug approval stat reports guide fda pathways https://www.statnews.com/2026/03/05/better-ibd-treatments-fda-flexibility-questions-readout-loud/ The Readout LOUD: Better IBD treatments and FDA questions | STAT Mar 5, 2026 - Will drugmakers finally be able to breach the efficacy ceiling in inflammatory bowel disease? And is the FDA being flexible enough with rare disease treatments? readout loud better ibd treatments fda https://www.statnews.com/pharmalot/2026/04/16/alzheimers-drugs-review-fda-panel-for-compounded-peptides/ Pharmalittle: Alzheimer's drugs reviewed, FDA panel to vet peptides | STAT Apr 16, 2026 - A new report released by Senate Democrats finds that prescription drug prices have continued to climb — in some cases, sharply. pharmalittle alzheimer drugs reviewed fda