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FDA-RELATED NEWS
 
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TXT Senators Demand HHS Reverse Autism-Related Web Site Changes
03/17/2026
 
 
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 White House Reportedly Moves to Oust Commissioner Makary
05/08/2026
 
 
TXT Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy
05/08/2026
 
 
TXT Postapproval Pregnancy Safety Studies Guidance Available
05/08/2026
 
 
TXT New CDER Biologics Compliance Program Explained
05/07/2026
 
 
TXT Report says Makary May Face Ouster Amid White House Tensions
05/07/2026
 
 
TXT CBER Acting Head Highlights Regulatory Flexibility, AI and Rare Disease Priorities
05/07/2026
 
 
TXT Advertising Experts Critique FDA’s Increasing Enforcement
05/07/2026
 
 
TXT Sanofi Seeks Removal of Tzield From FDA Priority Review Program
05/07/2026
 
 
TXT Brookings Economist Backs FDA Biosimilar Draft Guide
05/07/2026
 
 
TXT House Committee Would Limit Foreign Trial Data
05/07/2026
 
 
TXT 10 Observations in Somerset Therapeutics FDA-483
05/07/2026
 
 
TXT One-Day Inspection Pilot Underway at FDA
05/06/2026
 
 
TXT Makary Touts Hiring Push, Clinical Trial Reforms at FDLI
05/06/2026
 
 
TXT FDA Releases Bio-Thera Solutions FDA-483
05/06/2026
 
 
TXT Commissioner’s National Priority Voucher for Bizengri
05/06/2026
 
 
TXT Guidance on CMC Flexibility for Human CGTs
05/06/2026
 
 
TXT Expedite FDA Review of Breakthrough Mental Health Therapies: House Letter
05/06/2026
 
 
TXT Unetixs Vascular Selling Illegal Devices: FDA
05/05/2026
 
 
TXT FDA Hits Respilon Production for 5 CGMP Violations
05/05/2026
 
 
TXT Recent Accelerated Approval Path Changes Explained
05/05/2026
 
 
TXT FDA, TransCelerate Collaborate on Streamlined Safety Data Collection
05/05/2026
 
 
TXT 3 CGMP Issues At Active Cosmetics Manufacturing
05/05/2026
 
 
TXT Makary Outlines Sweeping Reforms to Speed Drug Development
05/04/2026
 
 
TXT High Court Pauses Limits on Mifepristone
05/04/2026
 
 
TXT Alnylam Pharma’s Web Promo is Misleading: FDA
05/04/2026
 
 
TXT Allergan’s Ireland Plant Hit With 483 After Inspection
05/01/2026
 
 
TXT PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance
05/01/2026
 
 
TXT Expanded Access Program for Promising Pancreatic Cancer Drug
05/01/2026
 
 
TXT Eugia Pharma Specialties FDA-483 Out
04/30/2026
 
 
TXT Keep GLP-1s Off Bulks List: FDA
04/30/2026
 
 
TXT Nubeqa TV Ad, Video Misleading: FDA
04/30/2026
 
 
TXT House Committee Advances FDA Funding Bill Amid Policy Disputes
04/30/2026
 
 
TXT FDA Panel Rejects Astrazeneca’s Camizestrant In Closely Watched Vote
04/30/2026
 
 
TXT Enrollment Halted in Newron’s Schizophrenia Study After Patient Death
04/30/2026
 
 
TXT Prospective AI Versioning Standard Needed: Post
04/29/2026
 
 
TXT Purdue Sentencing Sets $5.3 Billion in Criminal Penalties
04/29/2026
 
 
TXT Reviewers Brief ODAC on Camizestrant Concerns
04/29/2026
 
 
TXT Celgene Cell Therapy Facility Hit with Form 483
04/29/2026
 
 
TXT 8 Observations on Fujifilm Diosynth FDA-483
04/29/2026
 
 
TXT CGMP Violations at Lexia LLC
04/29/2026
 
 
TXT Multiple Violations in Foshan Miwei Cosmetics Inspection
04/28/2026
 
 
TXT CGMP Issues at Intas Dehradun Unit
04/28/2026
 
 
TXT Tavneos Withdrawal Sought Over Data Manipulation, Safety Risks
04/28/2026
 
 
TXT FDA Evaluating Measures to Modernize Clinical Trials
04/28/2026
 
 
TXT FDA’s Early QMSR Priorities Seen
04/28/2026
 
 
TXT 5 Observations on Excelvision FDA-483
04/28/2026
 
 
TXT Fast Track for Scancell iSCB1+ in Advanced Melanoma
04/28/2026
 
 
TXT FDA Still Weighing Potential CBER Director Candidates
04/28/2026
 
 
TXT Judge Dismisses Homeopathy Industry Challenge to FDA Policy Shift
04/27/2026
 
 
TXT Political Pressure on Psychedelics May Undermine FDA Approvals: Experts
04/27/2026
 
 
TXT FDA Set to Outline ‘Major Steps’ Toward Real-Time Clinical Trials
04/27/2026
 
 
TXT Incyte’s Niktimvo Web Site is Misleading: FDA
04/24/2026
 
 
TXT High-Risk Issue With Angiographic Syringes in Surgical Kits: FDA
04/23/2026
 
 
TXT FDA, CMS Unveil ‘RAPID’ to Speed Device Coverage Decisions
04/23/2026
 
 
TXT Loper Bright Affecting Regulation of Synthetic Biology: Column
04/23/2026
 
 
TXT Revive Rx FDA-483 Has 5 Repeat Observations
04/23/2026
 
 
TXT Global Calcium FDA-483 Has 6 Observations
04/23/2026
 
 
TXT Ban Mercury Amalgam Fillings: Petition
04/23/2026
 
 
TXT Gene Therapy Approved for Inherited Hearing Loss
04/23/2026
 
 
TXT FDA Not Pursuing Ban on Drug DTC Ads, Makary says
04/23/2026
 
 
TXT 2 Vet4U Inspection Observations
04/22/2026
 
 
TXT Redact CRLs for Unapproved Applications: Petition
04/22/2026
 
 
TXT Senate Democrats Target Trump Drug Pricing Deals
04/22/2026
 
 
TXT 4 Ways to Better Use CRISPR-Edited Therapies: Article
04/22/2026
 
 
TXT Reject Cipla NDA for Descovy Duplicate: Gilead
04/22/2026
 
 
TXT Warning Letter to Firm Over Weight-loss/Diabetes Drugs
04/22/2026
 
 
TXT FDA extends review for Sanofi’s subcutaneous Sarclisa
04/22/2026
 
 
TXT Multiple Violations at China’s Xiamen Kang
04/21/2026
 
 
TXT New FDA AEMS Dashboard Needs Context, Transparency: Professors
04/21/2026
 
 
TXT Makary Support Vouchers for Psychedelic Therapies
04/21/2026
 
 
TXT Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava
04/21/2026
 
 
TXT CGMP Violations at Par Health USA/Endo USA
04/21/2026
 
 
TXT FDA Lays Out Next Phase of Plan to Reduce Animal Testing
04/20/2026
 
 
TXT Trump Signs Executive Order to Accelerate Psychedelic Therapies
04/20/2026
 
 
TXT Padcev-Keytruda Combo for Broader Bladder Cancer
04/20/2026
 
 
TXT FDA Sets Higher Approval Bar for Passage Bio Dementia Therapy
04/20/2026
 
 
TXT Philips Wins Clearance for AI-powered Spectral CT System
04/17/2026
 
 
TXT Guidance on Impurity Standards For Fermentation-Based Antibiotics
04/17/2026
 
 
TXT Collins Presses for Faster Generic Competition at Hearing
04/17/2026
 
 
TXT White Paper on Improving Accelerated Approval Path
04/16/2026
 
 
TXT AdvaMed Recommendations for Class 2 Notification Exemption
04/16/2026
 
 
TXT Trump Names Erica Schwartz to Head CDC
04/16/2026
 
 
TXT Lilly to Seek FDA Approval for Foundayo in Diabetes
04/16/2026
 
 
TXT Kennedy Hearing Repeatedly Raised FDA Actions
04/16/2026
 
 
TXT Town Hall Discusses QMSR Basics and Answers Questions
04/15/2026
 
 
TXT Change Labeling for Hormonally Active Contraceptives: Petition
04/15/2026
 
 
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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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