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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 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 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 Regenxbio’s Complete Response Letter Released
03/03/2026
 
 
TXT FDA Working on Peptide Accessibility: Politico
03/03/2026
 
 
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 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
 
 
TXT Preemption Defense Opportunities, Pitfalls
02/20/2026
 
 
TXT FDA Cites Data Integrity, Quality Control at Aurobindo Facility
02/20/2026
 
 
TXT Court Dismisses Suit Seeking FDA Pathway for Alzheimer’s
02/20/2026
 
 
TXT CDER’s Hoeg has SSRIs, mAbs in Crosshairs
02/20/2026
 
 
TXT Petition Seeks Restrictions on Robotic Surgical Device
02/19/2026
 
 
TXT 19-page Lupin FDA-483 Out
02/19/2026
 
 
TXT JAMA Examines FDA’s Move Away From Advisory Committees
02/19/2026
 
 
TXT Industry GDUFA Reauthorization Counterproposals
02/19/2026
 
 
TXT ‘Objectionable Conditions’ in Bioresearch Monitoring Inspection
02/18/2026
 
 
TXT FDA Flip Flops; Agrees to Now Review Moderna Vaccine
02/18/2026
 
 
TXT 2025 Medical Device Recalls Down, Drug Recalls Up
02/18/2026
 
 
TXT FDA Officials Discuss One Trial Standard
02/18/2026
 
 
TXT FDA Accepts for Review Hansa Biopharma Imlifidase BLA
02/18/2026
 
 
TXT GLP-1 Crackdown, OTC Push and Faster Ph.1 Timelines: Makary
02/18/2026
 
 
TXT More Consistent Rare Disease Flexibility Needed: Attorneys
02/18/2026
 
 
TXT Rare Disease Innovation Hub 2026 Strategic Agenda
02/17/2026
 
 
TXT Debate Intensifies Over Politicization of mRNA Vaccines
02/17/2026
 
 
TXT FDA Warns Elanco Animal Health About Pradalex Ads
02/17/2026
 
 
TXT CGMP Issues at Australia’s Cosmetic Manufacturers Pty
02/17/2026
 
 
TXT Compass Pathways Reports 2nd Positive Trial for Depression Drug
02/17/2026
 
 
TXT Senate HELP Committee: 15 Ways to Reform FDA
02/17/2026
 
 
TXT FDA DTC Crackdown Reshapes Industry Creative Approach
02/17/2026
 
 
TXT FDA Shifts to Risk-Based Device Inspections under QMSR
02/13/2026
 
 
TXT PTC Yanks Translarna NDA After FDA Signals Data Shortfall
02/13/2026
 
 
TXT Cotton Urges FDA Probe Into Chinese APIs for GLP-1 Drugs
02/13/2026
 
 
TXT FDA Rejects Commissioner's Voucher Drug
02/13/2026
 
 
TXT FDA Should Move More Drugs OTC: Opinion
02/13/2026
 
 
TXT Common Violations in Recent DTC Letters from FDA
02/13/2026
 
 
TXT Antimicrobial Drug Duration of Use Guidance
02/12/2026
 
 
TXT Authorize Generic GLP-1s: Public Citizen
02/12/2026
 
 
TXT Court Says Warning Letter Can be Final FDA Action
02/12/2026
 
 
TXT Researchers Urge FDA Caution in Phasing Out Animal Testing
02/12/2026
 
 
TXT FDA Faces High Hurdle to Expand DTC Ad Disclosures: WLF
02/12/2026
 
 
TXT FDA OKs Pulling Boxed Warnings from 6 HRT Drugs
02/12/2026
 
 
TXT Legal Scholars Warn ‘Infringement by Label’ Will Harm Generics
02/12/2026
 
 
TXT Turmoil Mounts Under Prasad’s Leadership: WSJ
02/12/2026
 
 
TXT Inhaled Gene Therapy for Lung Cancer Gets ‘Expedited’ Status
02/11/2026
 
 
TXT FDA Tags Data Integrity, Inventory Lapses in AGC Biologics 483
02/11/2026
 
 
TXT FDA Hits Tremfya TV Ad as ‘False or Misleading’
02/11/2026
 
 
TXT CBER Head Overruled Staff on Moderna Flu Vaccine Filing
02/11/2026
 
 
TXT FDA ‘Not Serious’ About Mifepristone Review: GOP Senators
02/11/2026
 
 
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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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