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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 Celltrion’s Humira Biosimilar Now Interchangeable: FDA
04/16/2025
 
 
TXT Hill Staffer Graham Appointed to FDA Policy Office
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 Hims & Hers Scraps Compounded GLP-1 Pill Program
02/09/2026
 
 
TXT BIO Urges Broader Guidance on Monoclonal Antibody Safety Testing
02/09/2026
 
 
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 Congress Clarifies Orphan Drug Exclusivity & Generic Transparency
02/06/2026
 
 
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 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 U.S. Specialty Formulations FDA-483 Out
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 Aquestive’s Epinephrine Film Gets Complete Response
02/02/2026
 
 
TXT FDA Launches PreCheck Drug Manufacturing Pilot
02/02/2026
 
 
TXT Citizen Petition Seeks Database for Medical Device Labels
02/02/2026
 
 
TXT $17.9 Million Settlement in Generic Drug Price-Fixing Case
02/02/2026
 
 
TXT Complete Response on Pharming’s Pediatric sNDA for Joenja
02/02/2026
 
 
TXT Florida’s FDA-Authorized Canadian Drug Import Program Stalls
02/02/2026
 
 
TXT FDA Updates Device Inspection Program Due to QMSR Move
01/30/2026
 
 
TXT Senators Question HHS Oversight of TrumpRx Platform
01/30/2026
 
 
TXT FDA Releases Corrected Rejection Letter for Corcept NDA
01/30/2026
 
 
TXT Ultragenyx Resubmits BLA for Gene Therapy
01/30/2026
 
 
TXT Elevar Submits Lirafugratinib NDA for Bile Duct Cancer
01/30/2026
 
 
TXT Sen. Scott Bill to Require Country-of-Origin on Rx Labels
01/30/2026
 
 
TXT FDA Approves Yuvezzi Combination Eye Drop for Presbyopia
01/29/2026
 
 
TXT Agency Clarifies Clinical Decision Support Software
01/29/2026
 
 
TXT FDA Staffing Shortages are Lengthening Trial Planning
01/29/2026
 
 
TXT Kennedy Ally Says Makary Blocking Covid Shot Withdrawal
01/29/2026
 
 
TXT Suggestions to Revise Hatch-Waxman ‘Skinny Label’ Provisions
01/29/2026
 
 
TXT FDA Politicization Depth and Breadth ‘Unprecedented’: Professor
01/29/2026
 
 
TXT FDA Denies Ozempic Petition Without Substantive Comment
01/28/2026
 
 
TXT 124 Novel Medical Devices Authorized in 2025: Report
01/28/2026
 
 
TXT 2 Regenxbio Gene Therapies Get Clinical Holds
01/28/2026
 
 
TXT Neffy Broadcast Ad ‘False or Misleading’: OPDP
01/28/2026
 
 
TXT Public Citizen Sues Over Drug Price Deals
01/28/2026
 
 
TXT HHS OIG Outlines Safe Harbor for DTC Drug Sales
01/28/2026
 
 
TXT CGMP Issues at Malaysia’s Fulijaya Manufacturing
01/27/2026
 
 
TXT Using AI in Tumor Assessment
01/27/2026
 
 
TXT Roche Reports Positive Phase 2 Data for Obesity Drug
01/27/2026
 
 
TXT FDA Lifts Clinical Hold on Intellia’s Phase 3 Trial
01/27/2026
 
 
TXT Warning Letter Issued to Meridian Bioscience
01/27/2026
 
 
TXT Drug Companies Using AI to Speed Submissions
01/27/2026
 
 
TXT FDA Cites Pine Pharma Over Sterility, Quality Control
01/26/2026
 
 
TXT ‘Plausible Mechanism’ Drug Pathway Raises Process Concerns
01/26/2026
 
 
TXT Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy
01/26/2026
 
 
TXT Former CytoDyn CEO Sentenced to Prison
01/26/2026
 
 
TXT Advocacy Groups Press Congress on Biosimilar Legislation
01/23/2026
 
 
TXT FDA Reports Gains in Drug Inspection Program
01/23/2026
 
 
TXT Testing Deficiencies Cited at Asahi Kasei Finechem API Plant
01/23/2026
 
 
TXT FDA Highlights Expedited Pathways in Drug Approval Report
01/23/2026
 
 
TXT FDA Drug Ad Enforcement Letters Hit 25-Year High
01/22/2026
 
 
TXT Corcept Reports Promising Survival Data for Ovarian Cancer Drug
01/22/2026
 
 
TXT 6 Observations in Lupin Nagpur Inspection
01/22/2026
 
 
TXT Drug Shortage Announcements Can Lead to ‘Protective Purchasing’: USP
01/22/2026
 
 
TXT Draft Guide on Blood Pressure Monitoring Sensors
01/22/2026
 
 
TXT FDA Soliciting PreCheck Pilot Applications
01/21/2026
 
 
TXT Support for FDA Biosimilar Comparative Studies Draft Guidance
01/21/2026
 
 
TXT FDA Push to Move More Drugs to OTC Status
01/21/2026
 
 
TXT FDA Touts ImportShield Results
01/21/2026
 
 
TXT AdvaMed Urges FDA to Narrow Guidance on Device QMS
01/21/2026
 
 
TXT FDA Seeks More Data on Capricor Cell Therapy
01/20/2026
 
 
TXT ICH Drug Submission Quality Information Guidance
01/20/2026
 
 
TXT 4 CGMP Issues at Integrity Partners Facility
01/20/2026
 
 
TXT ‘Objectionable Conditions’ in Prodrome Sciences BIMO Inspection
01/20/2026
 
 
TXT Guide on Endpoints for Multiple Myeloma Accelerated Approval
01/20/2026
 
 
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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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