https://thecounter.org/common-swine-drug-under-review-fda-carbadox-carcinogen-phibro/
A common swine drug, banned in Canada, Australia, and the EU, is now under review by the FDA
Mar 15, 2022 - Not for the first time, the agency takes steps that could determine whether carbadox, a cancer-causing livestock drug, should remain on the market.
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https://thefederalist.com/2025/10/02/after-promising-review-of-deadly-abortion-pill-fda-greenlights-a-copycat-version/
Amid Review Of Deadly Abortion Drug, FDA Greenlights Copycat
Oct 2, 2025 - The generic mifepristone manufacturer Evita Solutions wants to ‘normalize abortion’ and make it ‘accessible to all.’
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https://canada-pharmacy-online.su/bioequivalence-studies-what-the-fda-requires-generic-drug-manufacturers-to-prove
Bioequivalence Studies: What the FDA Requires Generic Drug Manufacturers to Prove
The FDA requires generic drug makers to prove bioequivalence through rigorous studies showing their product absorbs like the brand-name version. Learn the...
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https://med.stanford.edu/news/all-news/2025/08/blood-cancer-drug.html
Stanford Medicine-led trial leads to FDA approval of drug for rare, deadly blood cancer
Fewer than half of people diagnosed with a subtype of myeloid/lymphoid neoplasms are alive one year later. A multicenter Phase 2 trial led by Stanford Medicine...
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https://www.streetwisereports.com/article/2025/11/13/lead-drug-faces-uncertain-fda-path-after-phase-3-miss.html?m_t=2025_11_13_12_09_11
Lead Drug Faces Uncertain FDA Path After Phase 3 Miss
aTyr Pharma Inc. (ATYR:NASDAQ) is seeking regulatory clarity following mixed Phase 3 results for its lead candidate efzofitimod in pulmonary sarcoidosis. The...
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https://www.businessinsider.com/analysts-fda-approval-of-amylyx-als-drug-relyvrio-amx0035-2022-9
Analysts on FDA Approval of Amylyx ALS Drug - Business Insider
Sep 30, 2022 - Analysts say the FDA's move to approve Axylyx's ALS drug is
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https://www.thehindu.com/sci-tech/health/agios-pharma-shares-jump-as-us-fda-expands-approval-for-blood-disorder-drug/article70473247.ece
Agios Pharma shares jump as U.S. FDA expands approval for blood disorder drug - The Hindu
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https://www.statnews.com/2025/09/25/new-acromegaly-drug-fda-approves-palsonify-crinetics-pharmaceuticals/
New acromegaly drug, Palsonify from Crinetics, wins FDA approval | STAT
Sep 25, 2025 - Crinetics Pharmaceuticals, a San Diego biotech with $3.2 billion market cap, tested 807 molecules on its way to developing this daily pill
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https://www.thehastingscenter.org/breakthrough-or-breakdown-should-the-fda-have-approved-the-new-alzheimers-drug-should-patients-take-it/
Should the FDA Have Approved the New Alzheimer’s Drug? - The Hastings Center for Bioethics
Jul 20, 2021 - Should Patients Take It? Monday, July 12, 2021 The Food and Drug Administration’s accelerated approval of a new Alzheimer’s drug has created a firestorm
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https://endpoints.news/fda-misses-pdufa-review-deadline-for-agios-thalassemia-drug/
FDA misses PDUFA review deadline for Agios’ thalassemia drug
Dec 8, 2025 - The FDA missed its target date for an approval decision on Agios’ thalassemia drug, another delay for the company as it tries to expand its reach in blood...
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https://www.prnewswire.com/news-releases/tr1x-announces-fda-clearance-of-first-investigational-new-drug-application-for-trx103-an-allogeneic-regulatory-t-cell-therapy-to-treat-autoimmune-diseases-302112587.html
Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an...
/PRNewswire/ -- Tr1X, Inc., an autoimmune and inflammatory disease cell therapy company focused on the development of novel allogeneic regulatory T cell...
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https://arstechnica.com/health/2025/11/fda-described-as-clown-show-amid-latest-scandal-top-drug-regulator-is-out/
FDA described as “clown show” amid latest scandal; top drug regulator is out - Ars Technica
Nov 5, 2025 - FDA regulator accused of using position to exact revenge on old business associate.
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https://www.medtechdive.com/news/Boston-Scientific-fda-approval-Agent-drug-coated-coronary-balloon/709053/
Boston Scientific gains FDA nod for drug-coated coronary balloon | MedTech Dive
BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.
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https://www.capitalbay.news/fda-approves-first-at-home-device-depression/
FDA Greenlights Non-Drug tDCS Device for Depression
Dec 11, 2025 - The FDA has approved the first prescription At-Home Brain Stimulation device (Flow FL-100) for MDD
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https://www.biopharmadive.com/news/FDA-approve-velsipity-etrasimod-ulcerative-colitis-pfizer/696551/
Pfizer wins FDA approval for its $7B colitis drug | BioPharma Dive
Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.
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https://www.drugdeliverybusiness.com/category/food-drug-administration-fda/
Food & Drug Administration (FDA) Archives - Drug Delivery Business
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https://www.biopharmadive.com/news/fda-rejects-akebia-anemia-drug-vadadustat/621304/
FDA rejects Akebia drug, dealing another blow to anemia pills | BioPharma Dive
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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...
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https://source.washu.edu/2023/04/drug-for-rare-form-of-als-based-in-part-on-washu-research-approved-by-fda/
Drug for rare form of ALS, based in part on WashU research, approved by FDA - The Source - WashU
Apr 26, 2023 - A new drug has been approved by the Food and Drug Administration (FDA) for a rare, inherited form of amyotrophic lateral sclerosis (ALS). Called tofersen, the...
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https://www.michaeljfox.org/news/new-parkinsons-drug-tavapadon-submitted-fda-review
New Parkinson’s Drug Tavapadon Submitted for FDA Review | Parkinson's Disease
A new drug application has been submitted to the Food and Drug Administration (FDA) for tavapadon, a once-daily, oral treatment to increase “on” time in...
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https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-drug-take-back-options
Drug Disposal: Drug Take-Back Options | FDA
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https://www.statnews.com/2025/12/19/cytokinetics-heart-drug-myqorzo-fda-approval/
Cytokinetics heart drug wins FDA approval, the biotech's first
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https://americanaffairsjournal.org/2024/02/foreign-government-subsidies-and-fda-regulatory-failures-are-causing-drug-shortages-in-the-united-states-heres-how-to-fix-it/
Foreign Government Subsidies and FDA Regulatory Failures Are Causing Drug Shortages in the United...
Feb 20, 2024 - The United States is suffering from the worst drug shortage crisis in recent history. Whether it is basic generic drugs, antibiotics, or chemotherapy drugs,...
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https://jrlcharts.com/2021/12/20/fda-approves-injectable-hiv-prevention-drug/
FDA Approves Injectable HIV Prevention Drug - JRL CHARTS
Jan 27, 2026 - The Food and Drug Administration announced on Monday that they have approved the first long-acting injectable HIV prevention medication for use as pre-exposure...
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https://clarivate.com/news/food-and-drug-administration-fda-and-clarivate-extend-material-transfer-agreement-for-three-additional-years/
Food and Drug Administration (FDA) and Clarivate Extend Material Transfer Agreement for Three...
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https://www.benzinga.com/news/fda/25/12/49186301/astrazenecas-hard-to-control-hypertension-drug-advances-with-fda-decision-expected-in-2026
AstraZeneca's Hard To Control Hypertension Drug Advances, With FDA Decision Expected In 2026 -...
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https://www.wired.com/story/my-son-pioneered-an-epilepsy-drug-derived-from-marijuana-an-fda-panel-just-approved-it/
It’s 4/20, and an FDA Panel Just OK’d a Drug Made From Marijuana | WIRED
Apr 20, 2018 - The treatment was fast-tracked for approval, and the first person to use the drug in the US was our writer's son.
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https://www.newsday.com/business/fda-makary-voucher-drug-reviews-n04455
Legal questions swirl around FDA's new expedited drug program, including who should sign off -...
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https://www.biopharmadive.com/news/global-blood-fda-approval-voxelotor-oxbryta/568039/
Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo | BioPharma...
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https://www.statnews.com/2024/09/26/fda-approves-schizophrenia-drug-cobenfy-bristol-myers-squibb/
FDA approves Bristol schizophrenia drug that could alter how disorder is treated
Sep 27, 2024 - Cobenfy works by stimulating a pair of muscarinic receptors in the brain, that, in turn, control the release of acetylcholine.
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https://www.biopharmadive.com/news/fda-fibrogen-advisers-vote-roxadustat-anemia/603458/
FDA advisers push back on FibroGen anemia drug | BioPharma Dive
Safety worries led to a near-unanimous vote against roxadustat in kidney disease patients, dimming the approval chances of what would be the first pill to...
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https://www.statnews.com/2025/11/02/fda-george-tidmarsh-regulator-kevin-tang/
FDA's top drug regulator, George Tidmarsh, resigns amid probe
Nov 3, 2025 - CDER Director George Tidmarsh is accused of seeking to use his authority to inflict financial harm on former associate Kevin Tang.
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https://www.psychiatrictimes.com/view/fda-clears-investigational-new-drug-application-for-tnx-102-sl-for-treatment-of-major-depressive-disorder
FDA Clears Investigational New Drug Application for TNX-102 SL for Treatment of Major Depressive...
Nov 24, 2025 - Psychiatric Times is the connection to Psychiatry and Mental Health, featuring clinical updates, expert views, and research news in multimedia formats.
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https://www.womansworld.com/aging/alzheimers/aduhelm-aducanumab-alzheimers-fda
Aduhelm: Alzheimer's Drug Approved by FDA | Woman's World
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https://endpoints.news/fda-pushes-back-ascendis-dwarfism-drug-decision-date-by-three-months/
FDA pushes back Ascendis’ dwarfism drug decision date by three months
Nov 26, 2025 - FDA extends review of Ascendis' TransCon CNP dwarfism treatment to Feb 2026, citing post-marketing study protocol. BioMarin's Voxzogo is only other approved...
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https://www.everydayhealth.com/migraine/fda-approves-new-migraine-drug-for-fast-symptom-relief/
FDA Approves New Migraine Drug for Fast Symptom Relief
Dec 30, 2019 - Oral dose of Ubrelvy reduces incapacitating pain within two hours, study finds.
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https://www.healio.com/news/neurology/20241204/fda-grants-orphan-drug-designation-to-oral-frontotemporal-dementia-treatment
FDA grants orphan drug designation to oral frontotemporal dementia treatment
The FDA has granted orphan drug designation to an oral, investigational, small-molecule therapeutic developed to treat frontotemporal dementia.In a press...
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https://www.biopharmadive.com/news/cytokinetics-fda-advisory-committee-vote-heart-failure/638762/
Cytokinetics heart drug voted down by FDA panel | BioPharma Dive
Following years of development, the biotech’s heart failure drug now faces another hurdle in its regulatory path forward, after a group of FDA advisers took...
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https://arstechnica.com/health/2025/12/more-fda-drama-top-drug-regulator-calls-it-quits-after-3-weeks/
More FDA drama: Top drug regulator calls it quits after 3 weeks - Ars Technica
Dec 2, 2025 - The last Trump official in the position left amid allegations of petty revenge.
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https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/
How Biogen used an FDA back channel to win Alzheimer's drug approval
Jul 31, 2023 - When Aduhelm’s prospects appeared dead, Biogen mounted a secret campaign to resurrect the drug and convince the FDA to approve it.
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https://thefederalist.com/2025/10/10/51-gop-senators-urge-hhs-fda-to-end-distribution-of-dangerous-abortion-drug/
51 GOP Senators Urge HHS, FDA To Restrict Abortion Drug
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https://www.biopharmadive.com/news/sanofi-ms-drug-tolebrutinib-FDA-clinical-hold-liver/626380/
FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects | BioPharma Dive
Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of...
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https://www.indiatoday.in/world/video/us-fda-approves-new-oral-thalassemia-drug-dr-sanjeev-bagai-calls-it-game-changer-ytvd-2846873-2026-01-05
US FDA Approves New Oral Thalassemia Drug; Dr Sanjeev Bagai Calls It 'Game Changer' -...
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https://www.progress.org.uk/glossary/fda-food-and-drug-administration/page/2/
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https://www.statnews.com/2025/12/11/fda-approves-new-gonorrhea-antibiotic-blujepa-from-gsk/
FDA approves first new gonorrhea drug in decades | STAT
Dec 11, 2025 - The drug, Blujepa, is from a new class of antibiotics, the first in decades to be approved as a treatment for gonorrhea.
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https://globalpharmacyplus.su/generic-drug-user-fee-amendments-how-gdufa-laws-speed-up-fda-review
Generic Drug User Fee Amendments: How GDUFA Laws Speed Up FDA Review
GDUFA laws let the FDA collect fees from generic drug makers to speed up reviews, reduce backlogs, and ensure safe, affordable medications reach patients...
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https://www.statnews.com/2025/06/18/fda-new-priority-review-voucher-program-analysis-of-risks-questions/
New FDA priority review drug program comes with risks, questions
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https://www.statnews.com/2025/12/19/fda-voucher-program-political-interference/
FDA voucher program has led to political interference in drug reviews, staffers say
Dec 19, 2025 - The “Commissioner’s National Priority Review Program” is seen as having fast-tracked reviews but at the expense of career scientists’ expertise.
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https://canceradvocacy.org/statement-on-dr-richard-pazdur-being-named-fda-center-for-drug-evaluation-and-research-director/
Statement on Dr. Richard Pazdur Being Named FDA Center for Drug Evaluation and Research Director -...
Nov 14, 2025 - November 13, 2025 – Cancer Nation applauds the choice of Dr. Richard Pazdur as the Director of the Center for Drug Evaluation and Research (CDER) at the Food...
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https://flipboard.com/@healthline/postmenopause-fda-approves-drug-to-help-boost-sex-drive/a-zC6A8wk1RSuJ6VJlDiTJ6g%3Aa%3A1747389465-8256327694%2Fhealthline.com
Postmenopause: FDA Approves Drug to Help Boost Sex Drive | Flipboard
Dec 18, 2025 - Healthline - The Food and Drug Administration (FDA) expanded its approval of a daily pill to treat low libido in females to include postmenopausal women up to...
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https://www.statnews.com/2025/12/03/tracy-beth-hoeg-lead-center-for-drug-evaluation-and-research/
Tracy Beth Høeg will lead FDA Center for Drug Evaluation and Research | STAT
Dec 4, 2025 - Høeg will be the fifth person to lead the center this year, and her appointment comes after Richard Pazdur’s abrupt retirement.
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https://www.progress.org.uk/glossary/fda-food-and-drug-administration/page/3/
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https://nationalhealthcouncil.org/letters-comments/nhc-comments-on-fda-2020-d-2316-for-benefit-risk-assessment-for-new-drug-and-biological-products-draft-guidance-for-industry/
NHC Comments on FDA-2020-D-2316 for Benefit-Risk Assessment for New Drug and Biological Products;...
Food and Drug Administration Dockets Management Staff (HFA-305) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: FDA-2020-D-2316 for “Benefit-Risk...
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https://www.statnews.com/2025/09/05/fda-digital-health-advisory-committee-november-meeting/
FDA will convene Digital Health Advisory Committee in November | STAT Food and Drug Administration...
Sep 5, 2025 - In the past, DHAC meetings have focused on artificial intelligence and medical devices.
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https://www.statnews.com/2025/11/21/top-leaders-not-fda-reviewers-voted-on-first-priority-voucher-drug/
FDA reviewers didn't get to vote on first priority voucher drug | STAT
Nov 21, 2025 - The FDA typically aims to avoid any appearance that political considerations are affecting drug approval decisions.
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https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-fdas-flush-list-certain-medicines
Drug Disposal: FDA’s Flush List for Certain Medicines | FDA
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The FDA Is Already Outsourcing Drug and Food Analysis to Error-Plagued AI Chatbot
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https://www.broadinstitute.org/news/fda-approves-first-cancer-drug-based-broad-institute-science
FDA approves first cancer drug based on Broad Institute science | Broad Institute
Collaboration between Broad Institute and Bayer leads to new treatment for a hard-to-treat type of lung cancer.
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FDA approves Aimmune drug as first treatment for peanut allergy | BioPharma Dive
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Jan 16, 2026 - Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to...
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https://www.statnews.com/2025/11/07/health-news-hep-b-vaccine-review-and-skepticism/
ACIP hep b vaccine, FDA drug vouchers: Morning Rounds
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https://www.biopharmadive.com/news/merck-enflonsia-rsv-antibody-fda-approval-clesrovimab/750123/
Merck antibody drug for RSV approved by FDA | BioPharma Dive
Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly became a blockbuster medicine...
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Trans medical care, FDA drug voucher program: Morning Rounds
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