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FDA-RELATED NEWS
 
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TXT FDA Remaking Inspection Priorities in Wake of Trump Cuts
04/02/2025
 
 
TXT FDA Says Rex Implants Illegally Marketing Devices
04/01/2025
 
 
TXT Bausch + Lomb Recalls enVista Intraocular Lenses
04/01/2025
 
 
TXT Axsome Solriamfetol Misses Primary Endpoint
04/01/2025
 
 
TXT 3 Observations on SKNV Outsourcing FDA-483
04/01/2025
 
 
TXT Multiple Violations in Next Science Inspection
04/01/2025
 
 
TXT FDA in Upheaval as Staff Layoffs Begin
04/01/2025
 
 
TXT RFK Jr. Upends His Promise to Enhance Transparency
04/01/2025
 
 
TXT Vanda Files NDA for Antipsychotic Drug
03/31/2025
 
 
TXT Trump Order Stifles Union Representation at FDA
03/31/2025
 
 
TXT Merck Touts Data in Pulmonary Arterial Hypertension
03/31/2025
 
 
TXT FDA Loses on Regulating Lab-Developed Tests
03/31/2025
 
 
TXT Medtronic Recalls Aortic Root Cannulas
03/31/2025
 
 
TXT Smallpox/Mpox Vaccine OK’d Despite CBER Turmoil
03/31/2025
 
 
TXT Milestone Misses Approval on Irregular Heart Beat NDA
03/28/2025
 
 
TXT FDA Green Lights At-Home Sexual Disease Test
03/28/2025
 
 
TXT Novartis Wins Expanded Pluvicto Use in Prostate Cancer
03/28/2025
 
 
TXT FDA Probes Data Integrity Concerns at India CRO
03/28/2025
 
 
TXT Sanofi’s New Hemophila Drug Approved
03/28/2025
 
 
TXT Advocates Blast Hiring ‘Quack’ for Autism Study
03/27/2025
 
 
TXT Bipartisan Patent Coordination Bill In
03/27/2025
 
 
TXT FDA to Cut Another 3,500 Employees Under HHS Plan
03/27/2025
 
 
TXT FDA Likely to Miss Review Deadlines: Staff
03/27/2025
 
 
TXT Prometheus, Owner Paying $550,000 for False Claims
03/27/2025
 
 
TXT Merck Seeks Approval for Subcutaneous Keytruda
03/27/2025
 
 
TXT Fresenius Prolia, Xgeva Biosimilars Approved
03/27/2025
 
 
TXT Makary Wins Senate Floor Vote on FDA Confirmation
03/26/2025
 
 
TXT CGMP Violations at China’s Yangzhou Sion
03/26/2025
 
 
TXT AstraZeneca Touts New Tagrisso Data
03/26/2025
 
 
TXT Exer Labs Illegally Marketing Exer Scan: FDA
03/26/2025
 
 
TXT Essure Issues Web Page Updated
03/26/2025
 
 
TXT Maintain, Apply Tabloid Guidance: Petition
03/26/2025
 
 
TXT Lytgobi Web Page False, Misleading: FDA
03/26/2025
 
 
TXT Approvable Letter for Sleep Apnea Device
03/26/2025
 
 
TXT Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J
03/26/2025
 
 
TXT 7 QS Violations in Dexcom Inspection
03/25/2025
 
 
TXT API Deviations at Aspen Biopharma Labs
03/25/2025
 
 
TXT Smiths Medical Recalls Endotracheal Tubes
03/25/2025
 
 
TXT Cassava Says Simufilam Failed in Alzheimer’s Study
03/25/2025
 
 
TXT Confirmatory Evidence in Non-Oncologic Rare Diseases
03/25/2025
 
 
TXT Regulate Silver Fluoride as Drug: Petition
03/25/2025
 
 
TXT Solriamfetol Phase 3 Trial Meets Endpoints
03/25/2025
 
 
TXT Vaccine Studies Should Have Transmission Rate Data: Marks
03/25/2025
 
 
TXT Fabhalta Approved for Rare Kidney Disease
03/24/2025
 
 
TXT Abbott IDE OK’d for Coronary Artery Blockages Trial
03/24/2025
 
 
TXT New FDA Building Completed as DOGE Cuts 27 Others
03/24/2025
 
 
TXT No Panel Review for Tonix Pharma Fibromyalgia NDA
03/24/2025
 
 
TXT Fast Track for Secretome Heart Failure Drug
03/24/2025
 
 
TXT Bard Recalls Rotarex Atherectomy Device Instructions
03/21/2025
 
 
TXT FDA Again Delays Non-Rx Drug Final Rule
03/21/2025
 
 
TXT Liver Cancer Combo Gets 2nd Complete Response Letter
03/21/2025
 
 
TXT Former FDA Deputy Bumpus Lands at Recursion
03/21/2025
 
 
TXT Tremfya Approved for Crohn’s Disease
03/21/2025
 
 
TXT Immunovant Delays Seeking Approval of Batoclimab
03/20/2025
 
 
TXT ‘Uncertainty Rules’ at FDA: Henry Miller
03/20/2025
 
 
TXT Calyxo Updates CVAC Aspiration Instructions
03/20/2025
 
 
TXT Baxter Spectrum Pump Recall is Class 1
03/20/2025
 
 
TXT FY 25 OTC Monograph Facility Fees Set
03/20/2025
 
 
TXT Complete Response on Lumbar Disc Herniation BLA
03/20/2025
 
 
TXT FDA Delays Decision on Breast Cryoblation Device
03/20/2025
 
 
TXT Pancreatic Cancer Drug Gets Orphan Status
03/20/2025
 
 
TXT Aspen Pharmacare CGMP Violations
03/19/2025
 
 
TXT FDA Accepts Alvotech AVT03 BLA
03/19/2025
 
 
TXT CGMP Violations at Canada’s Vegewax Candleworx
03/19/2025
 
 
TXT Smiths Medical Recalls Venous Access System
03/19/2025
 
 
TXT 2 ICH Guidelines Advance
03/19/2025
 
 
TXT Keytruda Full Approval for Gastroesophageal Cancer
03/19/2025
 
 
TXT Sarepta Reports Death Linked to Elevidys
03/18/2025
 
 
TXT Balance Drug Approval Flexibility, Evidence: Study
03/18/2025
 
 
TXT Physician-Investigator ‘Objectionable Conditions’
03/18/2025
 
 
TXT Advanced Pharmaceutical Repeat CGMP Violations
03/18/2025
 
 
TXT FDA Outlines Concerns with Unapproved GLP-1 Drugs
03/18/2025
 
 
TXT Medtronic Recalls Vantage Embolization Devices
03/18/2025
 
 
TXT FDA Rehires Fired Employees Due to Court Order
03/18/2025
 
 
TXT Incyte Plans NDA for JAK1 Inhibitor for Skin Condition
03/17/2025
 
 
TXT Ex-Magellan Execs Plead Guilty in Device Scandal
03/17/2025
 
 
TXT Hold Removed on vTv Therapeutics Diabetes Trial
03/17/2025
 
 
TXT Positive Hypoparathyroidism Trial Data: AstraZeneca
03/17/2025
 
 
TXT Thousands of FDA Employees Return to Office
03/17/2025
 
 
TXT Korro Bio Gets Orphan Status for KRRO-110
03/14/2025
 
 
TXT FDA Panel Determines Next Flu Vaccine Composition
03/14/2025
 
 
TXT Dr. Reddy’s Recalls Mislabeled Seizure Drug
03/14/2025
 
 
TXT CareFusion Recalls BD Alaris Systems Manager
03/14/2025
 
 
TXT FDA Top Lawyer Resigns After 2 Days on the Job
03/13/2025
 
 
TXT SpringWorks Therapeutics Awarded Priority Voucher
03/13/2025
 
 
TXT Q’Apel Selling Unapproved Aspiration System: FDA
03/13/2025
 
 
TXT One-third of MAUDE Reports Submitted Late: Study
03/13/2025
 
 
TXT Senate Committee Advances Makary’s FDA Nomination
03/13/2025
 
 
TXT Returning FDA Staff to Face Space, Parking Issues
03/13/2025
 
 
TXT Amgen Seeking Expanded Uplizna Use
03/13/2025
 
 
TXT FDA Device Data Integrity Notifications
03/13/2025
 
 
TXT CGMP Deviation in Chemspec Chemicals Inspection
03/12/2025
 
 
TXT 7 Acne Products Recalled for Benzene: FDA
03/12/2025
 
 
TXT Regulate NarxCare as Software as Medical Device: Petition
03/12/2025
 
 
TXT DoJ Lawyer Tapped as FDA Chief Counsel
03/12/2025
 
 
TXT Zenrelia Promotions ‘False and Misleading’: FDA
03/12/2025
 
 
TXT FDA Safety Alert on Immune Globulin Products
03/12/2025
 
 
TXT CGMP Deviations at Shree Jaya Unit
03/11/2025
 
 
TXT Linghai ZhanWang Records Show CGMP Violations
03/11/2025
 
 
TXT FDA Rejects All Mid-Link Technology Data
03/11/2025
 
 
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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;
  • The industry's most concise FDA news index;
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