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FDA-RELATED NEWS
 
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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 FDA Rejects CytoSorbents Bleed Reducing Device
05/02/2025
 
 
TXT Agency Accepts Oral Wegovy NDA for Obesity
05/02/2025
 
 
TXT FDA Rehiring Freedom of Information Staff
05/02/2025
 
 
TXT FDA Withdraws and Reissues 2 Guidances
05/02/2025
 
 
TXT Petition Seeks to Restrict Da Vinci Off-Label Use
05/02/2025
 
 
TXT FDA Rehiring Some Travel Support Staff
05/01/2025
 
 
TXT FDA Approves Element Science Wearable Defibrillator
05/01/2025
 
 
TXT Edwards Expands SAPIEN for Asymptomatic Patients
05/01/2025
 
 
TXT Semaglutide Wins in Steatohepatitis, Fibrosis
05/01/2025
 
 
TXT Drug Safety Monitoring Hurt by FDA Staff Cuts: Post
05/01/2025
 
 
TXT Placebo-controlled Trials Needed for Vaccines: HHS
05/01/2025
 
 
TXT FDA Extends Aficamten Review Over REMS Request
05/01/2025
 
 
TXT FDA OKs J&J’s Imaavy for Myasthenia Gravis
04/30/2025
 
 
TXT Unanimous SCOTUS Decision ‘Reassuring’: Post
04/30/2025
 
 
TXT Reopen FDA San Juan Lab: Representatives
04/30/2025
 
 
TXT Gilead Pays $202 Million Over Kickbacks Scheme
04/30/2025
 
 
TXT Makary Suggests Raising Bar on Covid Boosters
04/30/2025
 
 
TXT FDA Layoffs Affect Product Development: Post
04/30/2025
 
 
TXT Cosco International CGMP Inspection Findings
04/29/2025
 
 
TXT Bill Seeks to Kill Tax Deductions for DTC Ad Expenses
04/29/2025
 
 
TXT FDA Misses Review Decision on Stealth Bio NDA
04/29/2025
 
 
TXT Amazon Selling Unapproved, Misbranded Drugs: FDA
04/29/2025
 
 
TXT CGMP Issues at BEO Pharmaceuticals
04/29/2025
 
 
TXT Abeona Gains Approval of Resubmitted Zevaskyn
04/29/2025
 
 
TXT Learn from Exer Labs Warning on AI Use: Attorneys
04/29/2025
 
 
TXT Trial Shows Value of Immunotherapy in Some Cancers
04/29/2025
 
 
TXT No Broad FDA Reorganization Coming: Makary
04/29/2025
 
 
TXT J&J Touts Bladder Cancer Data in Recent NDA
04/28/2025
 
 
TXT Novavax, HHS Clarify on Post-approval Covid Study
04/28/2025
 
 
TXT Medtronic Files PMA for Hugo Urology Surgical Robot
04/28/2025
 
 
TXT BlackfinBio Plans Gene Therapy Trial
04/28/2025
 
 
TXT FDA Turns Down Telix Glioma Imaging Agent
04/28/2025
 
 
TXT An FDA Reviewer Exodus on the Horizon: Gottlieb
04/25/2025
 
 
TXT One-Third of Biosimilars Approved Not Launched: Report
04/25/2025
 
 
TXT FDA Clinical Hold on VYNE’s Psoriasis Drug
04/25/2025
 
 
TXT RFK Jr. Restoring FDA’s Freedom of Information Office
04/25/2025
 
 
TXT Breakthrough Status for Blood Pressure Therapy
04/25/2025
 
 
TXT Texas Court Gives FDA Win in Compounding Enforcement
04/25/2025
 
 
TXT Amneal Recalls Ropivacaine Hydrochloride Injection
04/24/2025
 
 
TXT FDA Alert on False Positive Lead Tests
04/24/2025
 
 
TXT Multiple Violations at Empower Pharma
04/24/2025
 
 
TXT Norwich Loses Generic Rifaximin Case
04/24/2025
 
 
TXT FDA Has ‘No Plans’ to Pull Abortion Pill: Makary
04/24/2025
 
 
TXT Abbott Recalls HeartMate Power Units
04/24/2025
 
 
TXT Staff Cuts Lead to Drug Data Gaps: Sources
04/24/2025
 
 
TXT ASCO Reaches Out to FDA, NIH, CMS
04/23/2025
 
 
TXT Cobenfy Effective as Schizophrenia Adjunct: Trial
04/23/2025
 
 
TXT Update Drug Labels with Obesity Info: Pitts
04/23/2025
 
 
TXT Lilly Sues 4 More Weight-Loss Drug Compounders
04/23/2025
 
 
TXT Alert Issued on Conavi’s Novasight Catheters
04/23/2025
 
 
TXT FDA Seeks Post-Marketing Commitment from Novavax
04/23/2025
 
 
TXT ESG NextGen is Live: FDA
04/23/2025
 
 
TXT Vanda Criticizes FDA on Tradipitant Hearing Delay
04/23/2025
 
 
TXT QS Violations at Noah Medical Corporation
04/22/2025
 
 
TXT Promising Enhertu+Perjeta Data in Breast Cancer
04/22/2025
 
 
TXT Lt. Governors Urge Trump to Support FDA, Other Agencies
04/22/2025
 
 
TXT ICU Medical Illegally Marketing Devices: FDA
04/22/2025
 
 
TXT CDER Continues Quality Management Program
04/22/2025
 
 
TXT FDA Integrity, Decision-Making at Risk: Blog
04/22/2025
 
 
TXT ICH Q1 Stability Testing Guide Out for Comment
04/22/2025
 
 
TXT FDA Alert on Compounded Topical Finasteride
04/22/2025
 
 
TXT Drug Promotion Leaders Leave Agency
04/22/2025
 
 
TXT Makary Says FDA Exploring Conditional Approvals
04/21/2025
 
 
TXT Leaked Budget Document Projects FDA Cuts: Report
04/21/2025
 
 
TXT Urgent Steps to Counter Need for Chinese Drugs: Exiger
04/21/2025
 
 
TXT FDA Restricting Industry Reps on Advisory Committees
04/21/2025
 
 
TXT FDA Inspections Will Suffer Under FDA Cuts: Lawyers
04/21/2025
 
 
TXT Bard Recalls BD 4 Fr. PowerPICC Catheters
04/21/2025
 
 
TXT Rare Disease Drug Development Articles
04/21/2025
 
 
TXT AI in Regulatory Science: Conference Report
04/16/2025
 
 
TXT Digital Health Technologies an FDA Priority: Article
04/16/2025
 
 
TXT Inspections Will Suffer Under FDA Cuts: Lawyers
04/16/2025
 
 
TXT Trump to FDA: Boost Generics, OTCs, Rx Imports
04/16/2025
 
 
TXT FDA Wants Contractors to Replace Some Fired Staff
04/16/2025
 
 
TXT 2 Medical Device FAQs Issued
04/16/2025
 
 
TXT Naturista Store Markets Unapproved Drug: FDA
04/15/2025
 
 
TXT CGMP Issues Found in PMS4PMS Inspection
04/15/2025
 
 
TXT FDA Clears eGenesis Perfusion Trial
04/15/2025
 
 
TXT Mural Oncology Scraps Nemvaleukin Alfa
04/15/2025
 
 
TXT FDA Authorizes Click’s Migraine Digital Therapeutic
04/15/2025
 
 
TXT China Stricter than U.S. in Cancer Drug Approvals: Study
04/15/2025
 
 
TXT Address Heart Failure Patient-Reported Outcome Issues
04/15/2025
 
 
TXT Recall All Humacyte Symvess Products: Petition
04/15/2025
 
 
TXT TEST
04/14/2025
 
 
TXT FDA Clears Bright Uro’s Urodynamics Device
04/14/2025
 
 
TXT Ironwood Needs Another Apraglutide Trial: FDA
04/14/2025
 
 
TXT Pfizer Nixes Oral Weight Loss Drug Development
04/14/2025
 
 
TXT FDA Seizes Counterfeit Ozempic in Supply Chain
04/14/2025
 
 
TXT Vanda Sues FDA to Allow Off-Label Promotion
04/14/2025
 
 
TXT Marks Warns of Growing Anti-Vaccine Stance
04/11/2025
 
 
TXT Self-Inject Vyvgart Hytrulo Approved
04/11/2025
 
 
TXT FDA OKs Opdivo + Yervoy in Liver Cancer
04/11/2025
 
 
TXT Sen. Paul Introduces Biosimilars Bill
04/11/2025
 
 
TXT RFK Jr. Misfires at FDA Headquarters Address
04/11/2025
 
 
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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;
  • 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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