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FDA-RELATED NEWS
 
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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
 
 
TXT Safety Labeling Changes Guidance
09/18/2025
 
 
TXT Committee Advances Pediatric Voucher Reauthorization
09/18/2025
 
 
TXT sGERD Drug Development Guidance
09/17/2025
 
 
TXT J&J Reports Positive Data in Psoriasis Drug
09/17/2025
 
 
TXT Exactech Pays $8 Million in Whistleblower Cases
09/17/2025
 
 
TXT Are FDA Advisory Committees Doomed?
09/17/2025
 
 
TXT Developing Disseminated Coccidiodomycosis Drugs
09/17/2025
 
 
TXT Lilly’s Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial
09/17/2025
 
 
TXT Ex-CDC Chief Says FDA Facing Similar Political Pressure
09/17/2025
 
 
TXT 4 Observations in Lupin Inspection
09/16/2025
 
 
TXT ‘Concerning’ DTC Ad Misbrands Hizentra: FDA
09/16/2025
 
 
TXT Multiple Violations in Illegal Marketing of SeniorLife.AI
09/16/2025
 
 
TXT Alert on Medline Kits with Medtronic Heart Catheter
09/16/2025
 
 
TXT CGMP Violations in Somerset Therapeutics Inspection
09/16/2025
 
 
TXT China Speeding Drug Approvals: CIRS Briefing
09/16/2025
 
 
TXT 40 DTC Untitled Letters Posted by FDA
09/16/2025
 
 
TXT Dexcom Recalls G7 and ONE + Apps
09/15/2025
 
 
TXT aTyr Pharma Reports Mixed Results in Lung Trial
09/15/2025
 
 
TXT Breakthrough Status for Gynecologic Cancer Therapy
09/15/2025
 
 
TXT FDA Cites Olympia Pharma Over GMPs
09/15/2025
 
 
TXT Krystal Wins Expanded Label for Gene Therapy
09/15/2025
 
 
TXT CBER Says AstraZeneca FluMist Ad Misled Viewers
09/12/2025
 
 
TXT Respironics Recalls DreamStation Ventilators
09/12/2025
 
 
TXT Makary JAMA Piece Explains DTC Ad Crackdown
09/12/2025
 
 
TXT Alternative Facility Assessment Tools Guidance
09/12/2025
 
 
TXT CBER to Host Gene Therapy Manufacturing Town Hall
09/12/2025
 
 
TXT FDA Pushes Plan to Scale Back Advisory Committees
09/12/2025
 
 
TXT Intercept Withdraws Ocaliva Amid Liver Safety Concerns
09/11/2025
 
 
TXT Ways FDA Can Modernize Drug Development
09/11/2025
 
 
TXT FibroGen Paying $1.25 Million to SEC
09/11/2025
 
 
TXT State of Clinical Trials CTTI Meeting Summary
09/11/2025
 
 
TXT FDA to Scrutinize AI-Powered Mental Health Devices
09/11/2025
 
 
TXT Capsida Pauses Gene Therapy Trial After Death
09/11/2025
 
 
TXT Prasad Reassumes Chief Medical/Scientific Officer Role
09/11/2025
 
 
TXT Expanded Approval for AZ’s Koselugo
09/10/2025
 
 
TXT Non-Opioid Analgesic Development Guidance
09/10/2025
 
 
TXT Apollo TMS Cleared for Depressed Adolescents
09/10/2025
 
 
TXT FDA Approves J&J’s New Bladder Cancer Therapy
09/10/2025
 
 
TXT Greenwich Gets Fast Track for Breast Cancer Therapy
09/10/2025
 
 
TXT FDA Orders Crackdown on Misleading Prescription Drug Ads
09/10/2025
 
 
TXT FDA Digital Health Leader Leaves for Mayo Clinic
09/10/2025
 
 
TXT Lexicon Submits New Data on Stalled Diabetes Drug
09/09/2025
 
 
TXT Capricor Posts Bytreldo CRL Response
09/09/2025
 
 
TXT NRx Petitions FDA to Ban Preservative in Ketamine
09/09/2025
 
 
TXT 7th Circuit Backs Dismissal of AbbVie False Claims Suit
09/09/2025
 
 
TXT Microbot Single-Use Robotic Endovascular System Cleared
09/09/2025
 
 
TXT MAHA Reports Aims to Improve Kids’ Health
09/09/2025
 
 
TXT CGMP API Deviations at Hikal Limited
09/09/2025
 
 
TXT Issues in 3 Trials Conducted by Detroit Doctor
09/09/2025
 
 
TXT Former CBER Therapeutics Deputy Anatol Joins Lilly
09/09/2025
 
 
TXT FDA Posts 2 Biosimilar Development Guides
09/08/2025
 
 
TXT Firm Pays $40 Million Over Adulterated Gowns
09/08/2025
 
 
TXT Gottlieb Warns HHS Could Undermine Pediatric Vaccines
09/08/2025
 
 
TXT FDA Guidance on Good Clinical Practice Principles
09/08/2025
 
 
TXT Lilly’s Jaypirca Shows Major Benefit in Leukemia Trial
09/08/2025
 
 
TXT Complete Response on Saol Therapeutics NDA
09/08/2025
 
 
TXT Green List to Block Illegal GLP-1 Imports: FDA
09/05/2025
 
 
TXT CERo Gets Fast Track for Leukemia Therapy
09/05/2025
 
 
TXT FDA Expert Panels Skirt Transparency Standards: Opinion
09/05/2025
 
 
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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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