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FDA-RELATED NEWS
 
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TXT FDA Enforcement Year in Review
01/27/2026
 
 
TXT Vanda Hetlioz sNDA Not Approvable, FDA Says
01/08/2026
 
 
TXT FDA Warns Apotex Canadian Manufacturing Site
11/05/2025
 
 
TXT FDA Takes Actions to Curb Autism
09/22/2025
 
 
TXT GDUFA Post-Warning Letter Meeting Guidance
06/18/2025
 
 
TXT Can Surprise Foreign Drug Inspections Boost Safety?
06/10/2025
 
 
TXT FDA Policy Head on Major Trump Changes at FDA
05/19/2025
 
 
TXT Vanda Tradipitant Scheduling Order Out
05/01/2025
 
 
TXT Little Trust in New Health Leaders: Poll
04/30/2025
 
 
TXT Hill Staffer Graham Appointed to FDA Policy Office
04/16/2025
 
 
TXT Celltrion’s Humira Biosimilar Now Interchangeable: FDA
04/16/2025
 
 
TXT Marks’ Firing Challenges RFK Jr.’s Fitness for Office
03/31/2025
 
 
TXT DOGE-Targeted FDA Lab to Remain Open
03/05/2025
 
 
TXT FDA Warning Letters Surge in FY2025, Report Finds
03/13/2026
 
 
TXT Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update
03/13/2026
 
 
TXT Uncertainty for Gene Therapy, Rare Disease & Vaccines in Prasad Exit Wake
03/13/2026
 
 
TXT Concerns Mount Over Fast Drug Review Voucher Program
03/13/2026
 
 
TXT Lilly Warns of Risk in Compounded Tirzepatide/Vitamin B12
03/12/2026
 
 
TXT Attorneys Discuss New FDA Draft NCI Guidance
03/12/2026
 
 
TXT Continue Modernizing Foreign Inspections: Study
03/12/2026
 
 
TXT FDA Draft Guidance for Medical Devices Intended for Weight Loss
03/12/2026
 
 
TXT AI Has Saved FDA 17,000 Hours: Makary
03/12/2026
 
 
TXT Sen. Johnson Probing FDA Rare Disease Denials
03/11/2026
 
 
TXT FDA Opens New, Searchable Adverse Event Platform
03/11/2026
 
 
TXT 4 Major Issues ‘Plaguing’ FDA: Newsweek
03/11/2026
 
 
TXT FDA Posts 483 Related to New Novo Nordisk Warning Letter
03/11/2026
 
 
TXT CGMP Violations in Tentamus India Inspection
03/11/2026
 
 
TXT Advita Ortho Hit with 7 QS Violations
03/11/2026
 
 
TXT FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site
03/10/2026
 
 
TXT Capricor’s Duchenne Cell Therapy BLA Resubmitted
03/10/2026
 
 
TXT FDA OKs Leucovorin for Ultra-Rare Brain Disorder, But Not Autism
03/10/2026
 
 
TXT CGMP Issues at Simtra BioPharma Solutions
03/10/2026
 
 
TXT Novo Nordisk PADE Reporting Violations
03/10/2026
 
 
TXT CGMP Violations at Fareva Morton Grove
03/10/2026
 
 
TXT Hims & Hers Super Bowl Ad Hit
03/10/2026
 
 
TXT FDA DTC Ad Crackdown Raises Legal Issues: Attorneys
03/10/2026
 
 
TXT Updated Guidance Clarifies Biosimilar Development Requirements
03/09/2026
 
 
TXT Incyte Gets ‘Complete Response’ Over Catalent Inspection Issues
03/09/2026
 
 
TXT Group urges Pfizer to Retract Threat on Drug Supplies
03/09/2026
 
 
TXT FDA Meets with States to Advance Canada Importation Plan
03/09/2026
 
 
TXT Ipsen Withdraws Tazverik Over Safety Data
03/09/2026
 
 
TXT FDA Cites Documentation Lapses at Maiva Pharma
03/06/2026
 
 
TXT Public Trusts FDA Career Scientists Over Agency Leadership
03/06/2026
 
 
TXT FDA Biologics Chief Vinay Prasad to Step Down in April
03/06/2026
 
 
TXT FDA Official Criticizes Advisory Committee Experts
03/06/2026
 
 
TXT Guidance Urges Comprehensive Responses to Inspection Findings
03/06/2026
 
 
TXT FDA Operations Chief Announces Retirement
03/05/2026
 
 
TXT Attorneys Review FDA’s New Inspection Approach for Devices
03/05/2026
 
 
TXT Regulate Outsourcing Ophthalmic Bevacizumab Products: Petition
03/05/2026
 
 
TXT Senate Committee Has More Drug Supply Questions
03/05/2026
 
 
TXT FDA Official Pushes Back in UniQure Dispute
03/05/2026
 
 
TXT FDA Approves Teclistamab Combination for Multiple Myeloma
03/05/2026
 
 
TXT ExThera Regulatory Chief Charged With Concealing Adverse Events
03/05/2026
 
 
TXT Petition Asks FDA to Investigate Mayo Robotic Mastectomy
03/05/2026
 
 
TXT Rep. Auchincloss Criticizes Commissioner’s Priority Voucher Program
03/04/2026
 
 
TXT Hoeg Recruits Petitioner Seeking New SSRI Warnings
03/04/2026
 
 
TXT Partial Hold on Myotonic Dystrophy Type 1 Therapy
03/04/2026
 
 
TXT FDA Posts Fujian Genohope FDA-483
03/04/2026
 
 
TXT FDA Denies Petition Seeking Accelerated Aging Therapies
03/04/2026
 
 
TXT Diasol Manufacturing Illegal Dialysis Disinfectants: FDA
03/04/2026
 
 
TXT BioMarin Natriuretic Peptide Petition Denied
03/04/2026
 
 
TXT Vanda Wins Long-Sought Hearing on Hetlioz sNDA for Jet Lag
03/03/2026
 
 
TXT Time to Update FDA SUPAC Guidances
03/03/2026
 
 
TXT ICH M14 Guide on Non-Interventional Study Principles Out
03/03/2026
 
 
TXT FDA Publishes ICH Postapproval Safety Data Guide
03/03/2026
 
 
TXT Fukuzyu FDA-483 Out
03/03/2026
 
 
TXT FDA Hits Novo Nordisk Over Ozempic Ad
03/03/2026
 
 
TXT Regenxbio’s Complete Response Letter Released
03/03/2026
 
 
TXT FDA Working on Peptide Accessibility: Politico
03/03/2026
 
 
TXT FDA Wants Randomized Trial for Huntington’s Gene Therapy
03/02/2026
 
 
TXT Pfizer CEO Concerned About FDA Vaccines Chief
03/02/2026
 
 
TXT Intellia Gets Hold Lifted on MAGNITUDE Phase 3 Trial in ATTR-CM
03/02/2026
 
 
TXT Ex-FDA Leaders Accuse Trump Admin of Distorting Contraceptive Science
03/02/2026
 
 
TXT FDA Employees Told Not to Use Claude AI in Tech Dispute
03/02/2026
 
 
TXT Researcher Critiques FDA Minimal Residual Disease Guidance
02/27/2026
 
 
TXT User Fee Negotiations Are Hung Up on America First Proposals
02/27/2026
 
 
TXT DoJ Supports Generic Drug Skinny Label Provision
02/27/2026
 
 
TXT Senate Committee Presses Pentagon Over FDA Import Exemptions
02/26/2026
 
 
TXT Lilly’s Oral GLP-1 Orforglipron Beats Oral Semaglutide in Trial
02/26/2026
 
 
TXT Makary Defends Approval Standards and Prasad’s Role
02/26/2026
 
 
TXT FDA Grants Accelerated Approval to Zongertinib for Lung Cancer
02/26/2026
 
 
TXT FDA Eyes Reviewer Bonuses to Speed Reviews
02/26/2026
 
 
TXT FDA Emphasizes Confidentiality as Foundation of Public Trust, Innovation
02/26/2026
 
 
TXT Advocates Urge Congress to Rein In FDA Review Uncertainty
02/26/2026
 
 
TXT FDA Division of Applied Regulatory Science Releases Annual Report
02/25/2026
 
 
TXT Rep. Gottheimer Introduces 5 Bipartisan Rare Disease Bills
02/25/2026
 
 
TXT CDER Plans 81 New, Revised Guidances in 2026
02/25/2026
 
 
TXT 5 CGMP Issues Cited in Ross Healthcare Inspection
02/25/2026
 
 
TXT Fresenius Recalls Ivenix Pumps Over Software Issue
02/25/2026
 
 
TXT Novo Nordisk Triple G Weight Loss Drug Shows Promise
02/24/2026
 
 
TXT Beta Bionics Gets Warning on iLet Bionic Pancreas
02/24/2026
 
 
TXT BioMarin Withdrawing Hemophilia A Gene Therapy
02/24/2026
 
 
TXT AdvaMed Presses FDA to Anchor Federal Strategy on Clinical AI
02/24/2026
 
 
TXT A.Nelson Warned on GMPs After Inspection
02/24/2026
 
 
TXT J&J Files sBLA for Imaavy in Rare Anemia
02/24/2026
 
 
TXT FDA Unveils Plausible Mechanism Framework Guidance
02/23/2026
 
 
TXT Novo Nordisk Obesity Drug Misses Endpoint
02/23/2026
 
 
TXT Industry Vet Named Head of FDA Digital Health Center
02/23/2026
 
 
TXT DTC Scrutiny Accelerating in 2026: Mintz
02/23/2026
 
 
TXT Partial Hold on MacroGenics’ Gynecologic Cancer Therapy
02/23/2026
 
 
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The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
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