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FDA-RELATED NEWS
 
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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 Sydnexis Pediatric Myopia Drug Meets Endpoints
11/04/2025
 
 
TXT FDA Warns Apotex Canadian Manufacturing Site
11/04/2025
 
 
TXT Can Industry Accept a Dysfunctional FDA?: Axios
11/04/2025
 
 
TXT Sarepta Completes Confirmatory Duchenne Trial
11/04/2025
 
 
TXT Compass Pathways Speeds COMP360 Launch
11/04/2025
 
 
TXT FDA OKs Aqua Medical IDE for Endoscopic Technology Trial
11/04/2025
 
 
TXT Reforms Needed to Boost Efficiency of Global Cancer Trials: Report
11/04/2025
 
 
TXT Lawsuit Against Tidmarsh Paints Troubling Picture
11/03/2025
 
 
TXT Top Drug Chief Resigns Amid Misconduct Probe, Lawsuit
11/03/2025
 
 
TXT Drug for Ultra-Rare Mitochondrial Disease Approved
11/03/2025
 
 
TXT Inspection of Alvotech’s Biosimilar Ends in Rejection
11/03/2025
 
 
TXT FDA Shifts Stance on AMT-130 BLA Data
11/03/2025
 
 
TXT FDA to Unveil Faster Pathway for Gene-Editing Therapies
10/31/2025
 
 
TXT Safety Data Update on Hintermann Ankle Device
10/31/2025
 
 
TXT Lilly Hopeful Obesity Pill Accepted in Voucher Program
10/31/2025
 
 
TXT J&J Seeks Stelara Expanded Use
10/31/2025
 
 
TXT Improving Cancer Trial Comparators: White Paper
10/30/2025
 
 
TXT Zydus Lifesciences FDA-483 Out
10/30/2025
 
 
TXT Clinical Hold on 2 Intellia Gene Therapy Trials
10/30/2025
 
 
TXT Senators Want Foreign Generic Drug Info
10/30/2025
 
 
TXT Hire Staff, Improve Morale, Cut INDs: Tidmarsh Goals
10/30/2025
 
 
TXT FDA Fast Track for Alphamab Cancer Drug
10/30/2025
 
 
TXT 2 QSR Violations at Qinjiang Kingphar Medical
10/29/2025
 
 
TXT FDA Drug Onshoring Policies Could Work: Attorneys
10/29/2025
 
 
TXT Multiple Violations Seen in Contec Medical Inspection
10/29/2025
 
 
TXT FDA Signals Pragmatic Push to Ease Biosimilar Development
10/29/2025
 
 
TXT Rare Cancer Seamless Clinical Trials
10/29/2025
 
 
TXT FDA Aims to Cut Comparative Efficacy Studies for Biosimilars
10/29/2025
 
 
TXT Revolution Medicines Wins Orphan Drug Status
10/28/2025
 
 
TXT Regeneron Gets ‘Complete Response’ on Eylea sBLA
10/28/2025
 
 
TXT Multiple Violations at 3 Royal Philips Facilities
10/28/2025
 
 
TXT Unicycive Plans OLC NDA Resubmission This Year
10/28/2025
 
 
TXT 4 Repeat CGMP Violations at Canada’s Innocore
10/28/2025
 
 
TXT Is FDA Lengthening Warning Letter Response Time?
10/28/2025
 
 
TXT Dr. Reddy’s Hit with 7-Item FDA-483
10/27/2025
 
 
TXT Intellia Pauses Gene Therapy Phase 3 Trials
10/27/2025
 
 
TXT Senate Letter Presses HHS on Foreign Generic Drugs
10/27/2025
 
 
TXT Guide on Device Quality Management Submission Info
10/27/2025
 
 
TXT FDA Expands Merck’s Winrevair Label
10/27/2025
 
 
TXT Inhibrx Posts Positive Phase 3 Results for Ozekibart
10/24/2025
 
 
TXT Sumitomo Pharma Gets FDA-483 After Inspection
10/24/2025
 
 
TXT Bayer Dual-Neurokinin Menopause Drug Approved
10/24/2025
 
 
TXT Sydnexis Hit with FDA Rejection for Myopia Drug
10/24/2025
 
 
TXT GSK’s Blenrep Approved for Market Reintroduction
10/23/2025
 
 
TXT Q&A on Expanded Access to Investigational Drugs
10/23/2025
 
 
TXT Tango Therapeutics Encouraging Cancer Drug Data
10/23/2025
 
 
TXT FDA Blocking Drug Info Consumers Need: Report
10/23/2025
 
 
TXT Office of New Drugs RTF MAPP
10/23/2025
 
 
TXT FDA Publishes Drug Filing Checklists to Avoid Delays
10/23/2025
 
 
TXT Alector Scraps Dementia Drug After Missing Key Endpoint
10/22/2025
 
 
TXT CGMP Issues Seen in Foshan Records Review
10/22/2025
 
 
TXT QS Violations in Dongguan Rainbow Tech Inspection
10/22/2025
 
 
TXT Report on Ways to Cut Reliance on Foreign Drugs
10/22/2025
 
 
TXT Makary Details DTC Enforcement Crackdown on Podcast
10/22/2025
 
 
TXT FDA Still Finding Issues at Nephron Pharmaceuticals
10/22/2025
 
 
TXT Moderna Quits CMV Vaccine After Phase 3 Failure
10/22/2025
 
 
TXT 3rd Patient-Focused Drug Development Guidance
10/22/2025
 
 
TXT sBLA for Padcev–Keytruda Combo in Bladder Cancer
10/22/2025
 
 
TXT QS, MDR, UDI Issues in Levo AG Inspection
10/21/2025
 
 
TXT Repeat CGMP Violations at Guangxi Yulin
10/21/2025
 
 
TXT Major Staff Losses at CDER and CBER Amid Shake-up
10/21/2025
 
 
TXT CGMP Violations Seen in BRS Services Inspection
10/21/2025
 
 
TXT GSK and Spero’s Antibiotic Positive Phase 3 Results
10/21/2025
 
 
TXT FDA Strengthens Tranexamic Acid Warning
10/21/2025
 
 
TXT FDA Contracts with ISMP on Medication Errors
10/21/2025
 
 
TXT Replimune BLA Resubmission for Melanoma Therapy
10/20/2025
 
 
TXT Cell, Gene Therapy Monitoring Guide Encouraging: Attorneys
10/20/2025
 
 
TXT AdvaMed Proposes ‘MAHA’ Pathway for Devices
10/20/2025
 
 
TXT Summit’s Ivonescimab Outperforms Tislelizumab in Trial
10/20/2025
 
 
TXT Kenvue Urges FDA to Reject Acetaminophen Petition
10/20/2025
 
 
TXT FDA Drug Approval Trends Slipping: Financial Analysts
10/20/2025
 
 
TXT 9 Vouchers Awarded Under New Priority Review Pilot
10/17/2025
 
 
TXT FDA OKs Iron-Based MRI Contrast Agent
10/17/2025
 
 
TXT Sen. Banks Presses FDA to Ramp Up Foreign Inspections
10/17/2025
 
 
TXT Autism Warning Marks Sharp Break from Standards: Attorneys
10/17/2025
 
 
TXT FDA Grants Priority Review to J&J’s Akeega sNDA
10/16/2025
 
 
TXT Novartis’ Fabhalta Slows Kidney Function Decline
10/16/2025
 
 
TXT Create ‘Drug Facts’ Box for DTC Ads: Column
10/16/2025
 
 
TXT Positive Results for Tecvayli/Darzalex Faspro Combo
10/16/2025
 
 
TXT AI, RWE in FDA Decisions
10/16/2025
 
 
TXT FDA Urges High Court Rejection of Vanda Petition
10/16/2025
 
 
TXT 3 Observations from Lupin Pithampur Inspection
10/16/2025
 
 
TXT FDA Accepts Chiesi’s Triple Combination Asthma Inhaler
10/15/2025
 
 
TXT Former Deputy Commissioner Bumpus Joins Charles River
10/15/2025
 
 
TXT Trial Success for Lilly Oral GLP-1
10/15/2025
 
 
TXT FDA Clears Roche Alzheimer’s Test
10/15/2025
 
 
TXT 6 Observations in Hetero Labs ’483
10/15/2025
 
 
TXT Pluses, Minuses to FDA Oncology Trial Guidance
10/15/2025
 
 
TXT FDA Clears First 1-Minute HIV Self Test
10/15/2025
 
 
TXT Allovate Illegally Marketing Allerdent, FDA Says
10/14/2025
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
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  • Summaries of the latest FDA Federal Register notices;
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