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FDA-RELATED NEWS
 
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TXT New Life Medical Selling Unapproved HCT/Ps
10/08/2025
 
 
TXT Create ‘Enhanced Drugs’ Pathway: Petition
10/08/2025
 
 
TXT Complement Therapeutics Gene Therapy Cleared for Trial
10/08/2025
 
 
TXT 3 CGMP Violations at Naturich Cosmetique
10/08/2025
 
 
TXT Trividia Recalls 1 Lot of Glucose Meters
10/08/2025
 
 
TXT FDA Rejects Xspray Pharma’s Leukemia Drug NDA
10/08/2025
 
 
TXT Lilly Partial Win Over FDA’s Biologic Classification
10/08/2025
 
 
TXT AstraZeneca Reports Favorable Hypertension Drug Data
10/07/2025
 
 
TXT Fire CDER, OGD Directors: Members of Congress
10/07/2025
 
 
TXT Statistical Analysis of FDA Warning Letters
10/07/2025
 
 
TXT FDA Warns Technological Medical
10/07/2025
 
 
TXT Multiple Creative Essences Violations
10/07/2025
 
 
TXT FDA Outlines Quicker Path for Lexeo Gene Therapy
10/07/2025
 
 
TXT Former CBER Head Marks Joins Eli Lilly
10/07/2025
 
 
TXT Clinical Hold Lifted on Neurizon ALS Drug
10/06/2025
 
 
TXT Priority Review for Orca Blood Cancer Cell Therapy
10/06/2025
 
 
TXT FDA Authorizes Cryoablation for Low-Risk Breast Cancer
10/06/2025
 
 
TXT 5 Items in Dr. Reddy’s Form FDA-483
10/06/2025
 
 
TXT Abivax Positive Data with Ulcerative Colitis Drug
10/06/2025
 
 
TXT FDA Pilots Speedier Reviews for U.S.-Made Generics
10/03/2025
 
 
TXT Makary Outlines Push to Modernize Drug Reviews
10/03/2025
 
 
TXT 2nd Generic Mifepristone Approved, Prompting Backlash
10/03/2025
 
 
TXT Agency Posts Form-483 for India Vaccine Maker
10/03/2025
 
 
TXT Rocket Pharma Withdraws Gene Therapy BLA
10/03/2025
 
 
TXT Repatha Phase 3 Trial Hits Primary Endpoints
10/02/2025
 
 
TXT Grifols Barcelona Facility Gets FDA-483
10/02/2025
 
 
TXT sBLA for Enhertu in High-Risk Early Breast Cancer
10/02/2025
 
 
TXT FDA Grants Fast Track for Alzheimer’s Drug
10/02/2025
 
 
TXT FDA Touts Sentinel Successes
10/02/2025
 
 
TXT FDA, Vanda Agree on Dispute Actions
10/02/2025
 
 
TXT CDRH Learn Module on Quality Management System
10/01/2025
 
 
TXT 17 New, 64 Revised Product-Specific Guidances
10/01/2025
 
 
TXT FDA Complete Response on Menkes Disease Drug
10/01/2025
 
 
TXT FDA Approves Novartis’ Rhapsido for Urticaria
10/01/2025
 
 
TXT CDRH Proposing 11 Guidances for FY 2026
10/01/2025
 
 
TXT Makary Outlines ‘Mission Critical’ Ops Under Shutdown
10/01/2025
 
 
TXT AbbVie BLA for Treating Rare Blood Cancer
10/01/2025
 
 
TXT WLF Wants End to FDA TV Ad ‘Crackdown’
10/01/2025
 
 
TXT FY 2026 GDUFA Science and Research Priorities
09/30/2025
 
 
TXT No IND Submitted for Study
09/30/2025
 
 
TXT Multiple Violations at Persōn & Covey
09/30/2025
 
 
TXT CDER Head Targets Surrogate Endpoints, Lupus Drug
09/30/2025
 
 
TXT Quantitative Medicine CoE Progress Update
09/30/2025
 
 
TXT Sharp Reductions in FDA Operations Under Shutdown: HHS
09/30/2025
 
 
TXT FDA Approves New Zoll Monitor/Defibrillator
09/30/2025
 
 
TXT OND Custom Medical Queries Are Useful: Article
09/30/2025
 
 
TXT New Guidance on Adaptive Clinical Trial Designs
09/29/2025
 
 
TXT CDRH Expands Recall of BD Alaris Pump Infusion Sets
09/29/2025
 
 
TXT FDA Protected From Firings During Shutdown: Makary
09/29/2025
 
 
TXT Novo Nordisk Resubmits BLA for Once-Weekly Insulin
09/29/2025
 
 
TXT FDA Tells IO Biotech to Delay Cancer Vaccine Filing
09/29/2025
 
 
TXT FDA Expands Device Early Alert Program
09/29/2025
 
 
TXT FDA Presses for Clinical Trial Reporting Compliance
09/26/2025
 
 
TXT AbbVie Files NDA for Parkinson’s Drug Tavapadon
09/26/2025
 
 
TXT Eyeglass Lenses OK'd for Pediatric Nearsightedness
09/26/2025
 
 
TXT FDA Approves New Drug for Acromegaly
09/26/2025
 
 
TXT FDA Rebukes Novartis Over Misleading TV Ad
09/26/2025
 
 
TXT Capricor Gets FDA OK on Duchenne BLA Refiling
09/25/2025
 
 
TXT FDA NextGen Submission Portal Guide
09/25/2025
 
 
TXT Public Confidence in FDA, Others Dropping: Survey
09/25/2025
 
 
TXT Lilly’s Inluriyo OK’d for Breast Cancer
09/25/2025
 
 
TXT CBER Posts 13 FDA Form-483s
09/25/2025
 
 
TXT Biolinq Gets De Novo for Glucose Sensor
09/25/2025
 
 
TXT Kennedy, Makary Pledge Mifepristone Review
09/25/2025
 
 
TXT FDA Ends Caprelsa REMS
09/25/2025
 
 
TXT University of Texas Clinical Trial Issues
09/24/2025
 
 
TXT Cell/Gene Therapy Postapproval Monitoring Guide
09/24/2025
 
 
TXT Cellebration Refusing to Provide Records to FDA
09/24/2025
 
 
TXT Acadia’s Phase 3 Trial of Intranasal Carbetocin Fails
09/24/2025
 
 
TXT Regenerative Therapies Expedited Programs
09/24/2025
 
 
TXT CGT Trial Innovative Designs Guidance
09/24/2025
 
 
TXT Interchangeable Biosimilar Bill Introduced
09/24/2025
 
 
TXT uniQure Reports Favorable Data in Huntington’s Trial
09/24/2025
 
 
TXT CGMP Violations at Janssen Vaccines S. Korea Plant
09/23/2025
 
 
TXT CGMP Deviations in Chengdu Records Review
09/23/2025
 
 
TXT FDA Issues Complete Response Letter for Apitegromab
09/23/2025
 
 
TXT Computer Software Assurance Guidance
09/23/2025
 
 
TXT 2 Items on Genzyme Ireland FDA-483
09/23/2025
 
 
TXT Cohance Lifescience FDA-483
09/23/2025
 
 
TXT Senators Want Overseas Drug Inspection Info
09/23/2025
 
 
TXT FDA Alert on Abiomed Impella Controllers
09/23/2025
 
 
TXT FDA Rejects Biogen's High-Dose Spinraza
09/23/2025
 
 
TXT FDA Rejects sNDA for Rexulti’s Use in PTSD
09/22/2025
 
 
TXT Guide on Enforcement Discretion for Emergency-Use IVDs
09/22/2025
 
 
TXT Stealth Wins Approval for Barth Syndrome Drug
09/22/2025
 
 
TXT FDA Extends Review on Sanofi Multiple Sclerosis NDA
09/22/2025
 
 
TXT Roche’s Giredestrant Shows Promise in Breast Cancer
09/22/2025
 
 
TXT FDA Issues Guidance on Malaria Drug Development
09/22/2025
 
 
TXT Device Inspections Show Tougher Enforcement: Law Firm
09/19/2025
 
 
TXT Rep. Pallone Blasts RFK Jr. Over Vaccine Changes
09/19/2025
 
 
TXT FDA OKs Medtronic’s Altaviva Implant for Incontinence
09/19/2025
 
 
TXT 10/9 Vaccines Panel to Recommend Flu Strain Selection
09/19/2025
 
 
TXT Merck’s Keytruda Qlex Approved by FDA
09/19/2025
 
 
TXT FDA Reverts Lab Test Reg. After Court Ruling
09/18/2025
 
 
TXT FDA OKs Expanded Labeling for Asthma Drug
09/18/2025
 
 
TXT Regeneron Plans Garetosmab FDA Submission
09/18/2025
 
 
TXT Leverage FDA ‘Alternative Tools’ Flexibility: Attorneys
09/18/2025
 
 
TXT Alert on Abbott’s TactiFlex Ablation Catheter
09/18/2025
 
 
TXT 6 Observations in Fagron Outsourcing Inspection
09/18/2025
 
 
TXT FDA Approves 2 Biocon Denosumab Biosimilars
09/18/2025
 
 
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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;
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  • Related industry news capsules;
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