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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 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
 
 
TXT Issues with AI-Enhanced Surgical Devices Cited
02/11/2026
 
 
TXT FDA Hits Sobi’s Vonjo TV Ad as Misleading
02/10/2026
 
 
TXT Repeat CGMP Violations at Signature Formulations
02/10/2026
 
 
TXT Aseptic Processing/Documentation Failures at Lonza Cell Therapy Facility
02/10/2026
 
 
TXT Rejection of Myopia Drug Raises Questions About Regulatory Consistency
02/10/2026
 
 
TXT Commissioner’s Voucher Program Q&A Published
02/10/2026
 
 
TXT No Informed Consent in 2 Clinical Investigations: FDA
02/10/2026
 
 
TXT FDA Reports Progress in MDUFA 6 Negotiations
02/10/2026
 
 
TXT Isotretinoin iPLEDGE REMS Modified
02/10/2026
 
 
TXT FDA Cites 2 Argenx TV ads for Vyvgart Hytrulo
02/09/2026
 
 
TXT Aurobindo’s Eugia Pharma Unit Cited After FDA Inspection
02/09/2026
 
 
TXT FDA Flags Novo Nordisk Over ‘Misleading’ Wegovy TV Spot
02/09/2026
 
 
TXT Regenxbio Gets ‘Complete Response’ for Gene Therapy
02/09/2026
 
 
TXT Partial Agreement in PDUFA Talks on Regulatory Science
02/09/2026
 
 
TXT BIO Urges Broader Guidance on Monoclonal Antibody Safety Testing
02/09/2026
 
 
TXT Hims & Hers Scraps Compounded GLP-1 Pill Program
02/09/2026
 
 
TXT Makary Warns ‘Illegal Copycat Drugs’ Will Face Swift Enforcement
02/06/2026
 
 
TXT Trust in FDA and CDC Remains Low After Vaccine Changes
02/06/2026
 
 
TXT FDA Flags Manufacturing/Quality Lapses at Ipca’s India API Plant
02/06/2026
 
 
TXT Congress Clarifies Orphan Drug Exclusivity & Generic Transparency
02/06/2026
 
 
TXT U.S. Specialty Formulations FDA-483 Out
02/05/2026
 
 
TXT ICH Patient Preference Guidelines Out for Comment
02/05/2026
 
 
TXT Bayer’s Asundexian Cuts Recurrent Stroke Risk in Phase 3
02/05/2026
 
 
TXT Industry Explains PDUFA 8 Facility Lifecycle Counterproposal
02/05/2026
 
 
TXT Telehealth Firm Undercuts Novo GLP-1 Pill Price: Reuters
02/05/2026
 
 
TXT J&J’s Cerenovus Recalls Neurovascular Coil Devices
02/05/2026
 
 
TXT Software Assurance Guidance Supplement
02/05/2026
 
 
TXT CGMP Violations Found in Cohance Lifesciences Inspection
02/04/2026
 
 
TXT Stakeholders’ Perspective on Nonprescription Drug Access
02/04/2026
 
 
TXT New Device Inspection Protocol Analyzed
02/04/2026
 
 
TXT Trump Officials Blocked Psychedelic Drug from Voucher Program
02/04/2026
 
 
TXT Funding Bill Reinstates FDA Pediatric Drug Voucher Program
02/04/2026
 
 
TXT Amgen Dismisses FDA Request to Withdraw Tavneos
02/04/2026
 
 
TXT Former FDA LASIK Official Morris Waxler Dies at 88
02/03/2026
 
 
TXT FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO
02/03/2026
 
 
TXT QS, MDR Violations at Mexico’s Unomedical Device
02/03/2026
 
 
TXT Abbott Diabetes Care QS Violations
02/03/2026
 
 
TXT Repeat CGMP Violations at Kirkman Drug Manufacturing
02/03/2026
 
 
TXT 12 Observations in Baxter Oncology FDA-483
02/03/2026
 
 
TXT Guide on Device Cybersecurity Released
02/03/2026
 
 
TXT Representative Questions Voucher Program Legality
02/03/2026
 
 
TXT FDA Cautious Stance on CAR-T Cell Therapies for Autoimmune Diseases
02/03/2026
 
 
TXT FDA Official’s Personal Legal Actions Trigger Ethics Probe
02/03/2026
 
 
TXT Florida’s FDA-Authorized Canadian Drug Import Program Stalls
02/02/2026
 
 
TXT Complete Response on Pharming’s Pediatric sNDA for Joenja
02/02/2026
 
 
TXT Aquestive’s Epinephrine Film Gets Complete Response
02/02/2026
 
 
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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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