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FDA-RELATED NEWS
 
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TXT Raskin, Others Seek FDA Meeting on Cuts
04/09/2025
 
 
TXT Kessler Slams Dangerous FDA Cuts at Hearing
04/09/2025
 
 
TXT Device Approvals Slow to 10-Year Low: Report
04/09/2025
 
 
TXT User Fee Programs are in Jeopardy: FDA Watchers
04/08/2025
 
 
TXT Restrict 2 Opioid Indications: Petition
04/08/2025
 
 
TXT ZyVersa Touts Approval Path for Kidney Disorder Drug
04/08/2025
 
 
TXT FDA ‘Like Flat Earthers Taking Over NASA’: Woodcock
04/08/2025
 
 
TXT FDA OKs Opdivo/Yervoy in Colon Cancer
04/08/2025
 
 
TXT Multiple Violations at EpiCare Acquisitions
04/08/2025
 
 
TXT Laboratory-Developed Test Decision Reviewed
04/08/2025
 
 
TXT Allogene Gets 3 Fast Tracks for Cell Therapy
04/07/2025
 
 
TXT Kennedy Senate Hearing Postponed
04/07/2025
 
 
TXT Teva Files sBLA to Expand Migraine Therapy’s Use
04/07/2025
 
 
TXT Device Reviews Will Now Take Longer: Shuren
04/07/2025
 
 
TXT Amgen’s Uplizna OK’d for Immunoglobulin G4 Disease
04/04/2025
 
 
TXT Could HHS Mea Culpa Lead to FDA Rehires?
04/04/2025
 
 
TXT House Committee Hearing on Reducing FDA Inefficiencies
04/04/2025
 
 
TXT Marks: RFK Jr. Wants FDA to Support Stem-cell Treatments
04/04/2025
 
 
TXT Draeger Recalls Flex 220 Breathing Circuit
04/04/2025
 
 
TXT CRL for Aldeyra’s Reproxalap for Dry Eye
04/03/2025
 
 
TXT Reorganization Will Block Information Flow
04/03/2025
 
 
TXT Makary Will Face Political Interference Soon: Gottlieb
04/03/2025
 
 
TXT BeiGene Drops Ociperlimab Development in Lung Cancer
04/03/2025
 
 
TXT Accelerated Approval Faces Scrutiny After Cancer Drug Review
04/03/2025
 
 
TXT Biogen Gets Fast Track for Alzheimer’s Therapy
04/02/2025
 
 
TXT Can FDA “Do More With Less?”: McClellan
04/02/2025
 
 
TXT Industry Sounds the Alarm on FDA Staff Cuts
04/02/2025
 
 
TXT Ocrevus IV Phase 3 Study Misses Primary Endpoint
04/02/2025
 
 
TXT Positive EDG-7500 Heart Drug Phase 2 Results
04/02/2025
 
 
TXT RFK Jr. Invited to Senate Hearing on HHS Reorganization
04/02/2025
 
 
TXT FDA Misses Novavax Covid Vaccine Review Action
04/02/2025
 
 
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
 
 
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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:
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