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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 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
 
 
TXT FDA Extends Molgramostim BLA Review for 3 Months
04/15/2026
 
 
TXT FDA’s No. 2 Brenner May Move to CDC Senior Role
04/15/2026
 
 
TXT FDA Updates Compliance Program for Biologic Drug Manufacturers
04/15/2026
 
 
TXT 2 CDER Postmarketing MAPPS Out
04/15/2026
 
 
TXT FDA Panel Meeting to Mull Adding Peptides to Compounding List
04/15/2026
 
 
TXT Quality, Data Integrity Issues Flagged at Indian API Maker Hikal
04/14/2026
 
 
TXT CGMP Violations Found at Medical Products Laboratories
04/14/2026
 
 
TXT Multiple Issues in Purolea Cosmetics Lab Inspection
04/14/2026
 
 
TXT Don’t Underestimate Device Quality System Inspection Changes: Column
04/14/2026
 
 
TXT Guidance on Sequencing Standards for Genome Editing Therapies
04/14/2026
 
 
TXT Exelixis Wants 505(b)(2) Cabometyx Restrictions
04/14/2026
 
 
TXT FDA Form 483 Response Guidance Outlined
04/14/2026
 
 
TXT FDA Urges Trial Sponsors to Disclose Missing Clinical Study Results
04/13/2026
 
 
TXT Greater Alignment Needed for External Control Arms: Stakeholders
04/13/2026
 
 
TXT Eye Doctor Emerges as Contender for CBER Head
04/13/2026
 
 
TXT Pfizer’s Adcetris Social Media Ads are Misleading: FDA
04/13/2026
 
 
TXT Cato Institute urges FDA overhaul to keep pace with AI
04/13/2026
 
 
TXT FDA rejects Replimune Melanoma Therapy Again
04/10/2026
 
 
TXT Rep. Auchincloss Seeks FDA Whistleblowers
04/10/2026
 
 
TXT Telix NDA Resubmission for Brain Cancer Imaging Agent
04/10/2026
 
 
TXT Vanda Blasts FDA Plan to Lengthen Drug Review Times
04/09/2026
 
 
TXT Will the Push for DTC Pre-Review Grow?
04/09/2026
 
 
TXT RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms
04/09/2026
 
 
TXT Alymsys Patient Brochure False or Misleading: FDA
04/09/2026
 
 
TXT America First Fee Incentives Discussed in PDUFA Meeting
04/09/2026
 
 
TXT Inspection Cites Thermo Fisher Manufacturing Facility
04/09/2026
 
 
TXT FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study
04/08/2026
 
 
TXT Mass Compounding Threatens FDA Enforcement: Column
04/08/2026
 
 
TXT FDA Budget Proposal Signals Push for Tighter Ad Oversight
04/08/2026
 
 
TXT Insmed Halts Brensocatib Program After Mid-Stage Trial Miss
04/08/2026
 
 
TXT See Supply Chain Strategy as Core Regulatory Function: Attorney
04/08/2026
 
 
TXT FDA Not Keeping Pace with Non-Oncology Basket Trials: Column
04/08/2026
 
 
TXT Medline Industries QS Violations Cited
04/07/2026
 
 
TXT FDA Opens READI-Home Innovation Challenge
04/07/2026
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
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You can rely on FDA Review to provide only what's important - in the most convenient and time-saving