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FDA-RELATED NEWS
 
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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 ‘Objectionable Conditions’ in Prodrome Sciences BIMO Inspection
01/20/2026
 
 
TXT Guide on Endpoints for Multiple Myeloma Accelerated Approval
01/20/2026
 
 
TXT Novo Nordisk Supplements Semaglutide Petition
01/20/2026
 
 
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 High Court Agrees to Hear ‘Skinny Label’ Dispute
01/16/2026
 
 
TXT Pazdur, Others Concerned About Voucher Program Integrity
01/16/2026
 
 
TXT Teclistamab Cuts Myeloma Risk of Progression by 71%: J&J
01/15/2026
 
 
TXT Scholar Rock Plans BLA Resubmission for Apitegromab
01/15/2026
 
 
TXT IND Review Procedures SOPP
01/15/2026
 
 
TXT Compounder Says Lilly, Novo Nordisk Violate Antitrust
01/15/2026
 
 
TXT Inspection Flags Sanitation, Quality Control Lapses at Biocon
01/15/2026
 
 
TXT 8 Observations in Shilpa Medicare ’483
01/15/2026
 
 
TXT Chinese Firms Asked About Counterfeit GLP-1 Drugs
01/15/2026
 
 
TXT 2 Voucher Program Drug Reviews Delayed: Reuters
01/15/2026
 
 
TXT Jazz Unloads Priority Voucher for $200 Million
01/14/2026
 
 
TXT FDA Hits Altor Bio Over Promo Violations
01/14/2026
 
 
TXT FDA, EMA Drug Development AI Principles
01/14/2026
 
 
TXT Multiple Violations Seen in ASP Global Inspection
01/14/2026
 
 
TXT Sclerotic’ FDA ‘Shuns Innovation’: Column
01/14/2026
 
 
TXT CGMP Issues Seen in Winder Laboratories Inspection
01/14/2026
 
 
TXT FDA Quietly ‘Retires’ Autism Bogus Therapies Page
01/14/2026
 
 
TXT CGMP Violation at India’s Chemspec Chemicals
01/13/2026
 
 
TXT BIMO Inspection Violation in India Hospital
01/13/2026
 
 
TXT FDA Cites Cancer Drug Television Ad
01/13/2026
 
 
TXT Remove Suicide Warning from GLP-1 Drugs: FDA
01/13/2026
 
 
TXT Ways for FDA to Modernize Biotech Regulation
01/13/2026
 
 
TXT Pazdur Warns About Political Interference, Upheaval At FDA
01/13/2026
 
 
TXT FDA Extends Review for Filspari in Kidney Disease
01/13/2026
 
 
TXT 35 Items on CDER CY2026 Guidance Agenda
01/13/2026
 
 
TXT Pediatric Menkes Disease Drug Approved
01/12/2026
 
 
TXT FDA Cites Aurobindo for Drug Supply Security Lapses
01/09/2026
 
 
TXT AVID Medical Recalls Organ Recovery Bags
01/09/2026
 
 
TXT FDA Flags Deficiencies in Aquestive’s Anaphylm NDA
01/09/2026
 
 
TXT Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys
01/08/2026
 
 
TXT FDA Flags BeOne Tevimbra Promotional Materials
01/08/2026
 
 
TXT PDUFA 8 Negotiations on RWE, First-Cycle Reviews
01/08/2026
 
 
TXT Harvard Law Hits User Fees Over ‘Corporate Capture’
01/08/2026
 
 
TXT Moonlake Immunotherapeutics Plans BLA Submission
01/08/2026
 
 
TXT GSK Hepatitis B Drug Hits Trial Marks
01/08/2026
 
 
TXT Drug, Biologic Approvals Drop in 2025
01/08/2026
 
 
TXT Makary Touts Less Oversight on Wearables
01/07/2026
 
 
TXT CGMP Violations at Absolutely Natural
01/07/2026
 
 
TXT 3 Observations in Lonza Guangzhou FDA-483
01/07/2026
 
 
TXT Esperion TV Spot for Nexlizet False, Misleading: FDA
01/07/2026
 
 
TXT Petition Seeks Risk-Based Peptide Framework
01/07/2026
 
 
TXT RWE, 510(k) TTD Discussed in MDUFA 6 Reauthorization
01/07/2026
 
 
TXT Hoeg, Prasad Draw Vaccine Concerns
01/06/2026
 
 
TXT CRL for Sanofi Multiple Sclerosis Drug
01/06/2026
 
 
TXT FDA Cites Dr. Reddy’s Labs Over Inspection Findings
01/06/2026
 
 
TXT ‘Skinny Label’ Safe Harbor Bills Introduced
01/06/2026
 
 
TXT Tower Laboratories CGMP Violations
01/06/2026
 
 
TXT Repeat CGMP Violations Seen in LiquidCapsule Inspection
01/06/2026
 
 
TXT Two Digital Health Guidances Published
01/06/2026
 
 
TXT End-of-December Warning Letters
01/06/2026
 
 
TXT FDA Town Hall on Quality Management System Regulation
01/06/2026
 
 
TXT First Cycle Review Metrics Debated at PDUFA Session
01/06/2026
 
 
TXT FDA Guidance on Bioresearch Monitoring Inspections
12/19/2025
 
 
TXT Is Political Pressure Corrupting New FDA Voucher Program?
12/19/2025
 
 
TXT FDA Tumult Keeps Makary Under Microscope: NYT Article
12/19/2025
 
 
TXT FDA Cites GSK Hungary Vaccine Plant
12/19/2025
 
 
TXT AstraZeneca Pulling Andexxa From Market Due to Safety
12/19/2025
 
 
TXT Cobenfy TV Spot ‘False or Misleading’: FDA
12/18/2025
 
 
TXT UBI FDA-483 Has 5 Observations
12/18/2025
 
 
TXT Lilly’s Oral GLP-1 Maintains Weight Loss After Switch
12/18/2025
 
 
TXT Novo Nordisk Files CagriSema NDA for Weight Loss
12/18/2025
 
 
TXT FDA Sends Warning Letters to Makers of Breast Binders
12/18/2025
 
 
TXT PDUFA Talks Hit Snag on Review Timelines/Transparency
12/18/2025
 
 
TXT Clinical Hold on Lung Cancer Trial After Deaths
12/18/2025
 
 
TXT Congressional Dems Want ‘Drug Deal’ Information
12/18/2025
 
 
TXT FDA Warns Catalent Indiana for CGMP Lapses
12/17/2025
 
 
TXT Change Premarin Prescribing Info to Include Equilin: Petition
12/17/2025
 
 
TXT FDA Agentic AI Deployment Raises Concerns
12/17/2025
 
 
TXT GSK Long-Acting Biologic Approved for Asthma
12/17/2025
 
 
TXT FDA Easing Drug Approval Standards: Column
12/17/2025
 
 
TXT Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths
12/17/2025
 
 
TXT Medical Device RWE Guidance
12/17/2025
 
 
TXT Merck Cholesterol, Cancer Drugs Added to Voucher Program
12/17/2025
 
 
TXT 3D Imaging CGMP and Listing Violations
12/16/2025
 
 
TXT FDA Extends Review Timeline for Aldeyra’s Dry Eye Drug
12/16/2025
 
 
TXT Guide to Increase Female Enrollment in Trials
12/16/2025
 
 
TXT Trump Taps Controversial Figure to Lead Cancer Panel
12/16/2025
 
 
TXT 7 Observations on ProRx FDA-483
12/16/2025
 
 
TXT Microvascular Tissue Marketing Unapproved New Drug
12/16/2025
 
 
TXT FDA Commissioner Defends Vaccine Stance, Transparency Push
12/16/2025
 
 
TXT Makary Says ‘No Plans’ for Covid Vaccine Boxed Warning
12/16/2025
 
 
TXT Sanofi Scraps Tolebrutinib MS Filing after Phase 3 Miss
12/15/2025
 
 
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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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