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FDA-RELATED NEWS
 
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TXT Travere Therapeutics Plans Filspari sNDA
02/12/2025
 
 
TXT Bioresearch Monitoring Issue at ISOThrive
02/12/2025
 
 
TXT CGMP Deviations at Wuhu Nuowei Chemistry
02/12/2025
 
 
TXT Olympus Recalls Bronchoscope Guide Sheaths
02/12/2025
 
 
TXT DoJ Probing Inspire Marketing, Reimbursement
02/12/2025
 
 
TXT FDA Clarifies Compounded GLP-1 Enforcement
02/12/2025
 
 
TXT Regeneron BLA Resubmitted for Multiple Myeloma
02/11/2025
 
 
TXT Change FDA AI Policies: Gottlieb
02/11/2025
 
 
TXT Strukmyer Medical CGMP Violations
02/11/2025
 
 
TXT Chengdu Records Review Finds CGMP Deviations
02/11/2025
 
 
TXT Court Orders FDA to Restore ‘Gender’ Web Pages
02/11/2025
 
 
TXT Change FDA Approach to Antibiotic Approval: Column
02/11/2025
 
 
TXT Breakthrough Status for Knee Arthritis Device
02/11/2025
 
 
TXT CA Man Sentenced Over Unapproved Drugs
02/10/2025
 
 
TXT Sentec/Percussionaire Breathing Circuit Recalled
02/10/2025
 
 
TXT Pliant Pauses Bexotegrast Trial for Safety Review
02/10/2025
 
 
TXT Guide on IRB Written Procedures
02/10/2025
 
 
TXT Boehringer Ingelheim Plans NDA for Lung Disease
02/10/2025
 
 
TXT Tempest Gets Fast Track for Amezalpat
02/10/2025
 
 
TXT Roche Shares Positive Data on Gazyva
02/07/2025
 
 
TXT Lawmakers Urge FDA to Block Super Bowl Drug Ad
02/07/2025
 
 
TXT Adicet Wins Fast Track for Lupus Cell Therapy
02/07/2025
 
 
TXT AbbVie Antibiotic OK’d for Abdominal Infections
02/07/2025
 
 
TXT Senate Dems Denounce FDA Communication Freeze
02/07/2025
 
 
TXT Use Preemption in ‘Failure-to-Market’ Cases: PRI
02/06/2025
 
 
TXT Court Threatens ‘Practice of Medicine’ Defense: Attorneys
02/06/2025
 
 
TXT Medline Catheter Recall is Class 1
02/06/2025
 
 
TXT Trump to Fire ‘Thousands’ of HHS Workers: Report
02/06/2025
 
 
TXT Cancer Drug Tabloid ANDA Restrictions Sought
02/06/2025
 
 
TXT Fast Track Status for Crohn’s Imaging Agent
02/06/2025
 
 
TXT Diabetes Device Smartphone Alerts Malfunctioning: FDA
02/05/2025
 
 
TXT More States Want to Import Drugs: Bloomberg
02/05/2025
 
 
TXT Ziftomenib NDA Due in 2nd Quarter: Kura/Kyowa
02/05/2025
 
 
TXT Baxter Recalls Life2000 Ventilators
02/05/2025
 
 
TXT Monlunabant Trial Misses End Point in Kidney Trial
02/05/2025
 
 
TXT CGMP Violations in Imperial Palace Records
02/05/2025
 
 
TXT BioStem Illegally Marketing Cellular Products: FDA
02/05/2025
 
 
TXT Global Calcium CGMP Deviations
02/04/2025
 
 
TXT CGMP Issues in China University Contract Lab
02/04/2025
 
 
TXT Trokamed Sheath Instructions Update is Class 1: FDA
02/04/2025
 
 
TXT Supernus Wins OK for Parkinson’s Drug
02/04/2025
 
 
TXT Bard Pays $17 Million to Resolve Kickback Charges
02/04/2025
 
 
TXT Feds Sued Over Removing Web Site Health Info
02/04/2025
 
 
TXT RFK Jr.'s HHS Nomination Moves to Senate Floor
02/04/2025
 
 
TXT Medtronic Recalls Cerebrospinal Fluid Drain Device
02/03/2025
 
 
TXT 2 Guides on Cell/Tissue Disease Transmission Delayed
02/03/2025
 
 
TXT Olympus Recalls Endoscope Accessory
02/03/2025
 
 
TXT Lawyers Critique Guide on Unapproved Use Dissemination
02/03/2025
 
 
TXT Pfizer Seeks Braftovi Full Approval in Colon Cancer
02/03/2025
 
 
TXT FDA Clears Hearing Aid/Smart Glasses
02/03/2025
 
 
TXT Vertex Non-Opioid New Pain Drug Approved
01/31/2025
 
 
TXT Info Collection on Rx Labeling Requirements
01/31/2025
 
 
TXT Biosimilar User Fees Info Collection Revised
01/31/2025
 
 
TXT FDA Alert on Fresenius Kabi Infusion Pumps
01/31/2025
 
 
TXT Neo-Tee T-Piece Resuscitators Recalled
01/31/2025
 
 
TXT Guide on Reducing Sepsis from Cell/Tissue Products
01/31/2025
 
 
TXT Senators Urge PhRMA to Support DTC Advertising Bill
01/31/2025
 
 
TXT Inhibikase Therapeutics Pulls Plug on Parkinson’s Drug
01/30/2025
 
 
TXT Nova Bio Recalls Glucose Meters
01/30/2025
 
 
TXT Trial Speed Seen as Key to Accelerated Approvals
01/30/2025
 
 
TXT Merck Stopping Winrevair Trial as Benefit Is Already Seen
01/30/2025
 
 
TXT Multiple Violations Cited at ProRx Outsourcing Facility
01/30/2025
 
 
TXT Cybersecurity Vulnerabilities in 2 Patient Monitors
01/30/2025
 
 
TXT Committee Chair Struggles to Support Kennedy
01/30/2025
 
 
TXT FDA Clears Roche Lipoprotein (a) Assay
01/29/2025
 
 
TXT Orphan Drug Designation for Marsh Lymphoma Drug
01/29/2025
 
 
TXT Adial Finishes Alcohol Abuse Drug PK Study
01/29/2025
 
 
TXT Trust in Health Agencies Continues Decline: KFF
01/29/2025
 
 
TXT Better Vaccine Communication Needed: Column
01/29/2025
 
 
TXT FDA Modernization Act 3.0 Reintroduced
01/29/2025
 
 
TXT RFK Jr. Grilled by Dems at Confirmation Hearing
01/29/2025
 
 
TXT FDA Accepts BLA for Alvotech’s Simponi BLA
01/29/2025
 
 
TXT Additional Ozempic Indication Approved
01/28/2025
 
 
TXT Enhertu Approval Broadens Breast Cancer Use
01/28/2025
 
 
TXT No Informed Consent at Trial Site: FDA
01/28/2025
 
 
TXT 2 Firms Illegally Selling Biologics: FDA
01/28/2025
 
 
TXT FDA Priority Review for New Merck Welireg Indication
01/28/2025
 
 
TXT AI Optics Handheld Retinal Imager Cleared
01/28/2025
 
 
TXT TerSera Wants Prialt ANDA Conditions
01/28/2025
 
 
TXT RFK Jr.’s Cousin Trashes Him on Eve of Hearing
01/28/2025
 
 
TXT Provepharm Recalls Phenylephrine HCl
01/27/2025
 
 
TXT Once Monthly Leqembi for Alzheimer’s Approved
01/27/2025
 
 
TXT Pfizer Pays $60 million to Settle Biohaven Kickbacks
01/27/2025
 
 
TXT Vanda Files NDA for Motion Sickness Drug
01/27/2025
 
 
TXT Stroke Device Cleared for Larger Catheters
01/27/2025
 
 
TXT Fast Track for Prostate Cancer Imaging Drug
01/24/2025
 
 
TXT ALX Oncology Seeking Accelerated OK for Evorpacept
01/24/2025
 
 
TXT FDA Approves Medexus Leukemia NDA
01/24/2025
 
 
TXT FDA Delays Non-Rx Drug Final Rule
01/24/2025
 
 
TXT CDRH’s Sara Brenner Elevated to Acting Commissioner
01/24/2025
 
 
TXT Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer
01/24/2025
 
 
TXT FDA Will Review Biogen Spinraza sNDA
01/23/2025
 
 
TXT FDA Removes ‘Diversity’ Docs From Web Site
01/23/2025
 
 
TXT Former FDA Women’s Health Head Wood Dies
01/23/2025
 
 
TXT FDA Extends Review of Stealth Bio NDA
01/23/2025
 
 
TXT Continue Strong Compliance, Quality Programs: Attorneys
01/23/2025
 
 
TXT Implement Digital Technologies Carefully: GE HealthCare
01/23/2025
 
 
TXT Durbin, Grassley Reintroduce Drug Ad Price Bill
01/23/2025
 
 
TXT New Copaxone Boxed Warning
01/22/2025
 
 
TXT CBER Approved 67 Products in 2024: Report
01/22/2025
 
 
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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;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving