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FDA-RELATED NEWS
 
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TXT Former FDA Staff Chief Joins Hogan Lowells
08/05/2025
 
 
TXT Vertex Signal Inhibitor VX-993 Misses Trial Goal
08/05/2025
 
 
TXT Dyne Gets Breakthrough Status for Duchenne Therapy
08/04/2025
 
 
TXT TransMedics Gets Heart Trial Conditional Approval
08/04/2025
 
 
TXT Philips Respironics Recalls Ventilators
08/04/2025
 
 
TXT Turmoil Led to Pazdur Overriding BLA Decision: Report
08/04/2025
 
 
TXT HHS’ Sean Keveney Named FDA Chief Counsel
08/04/2025
 
 
TXT Regeneron Odronextamab BLA Rejected Again
08/01/2025
 
 
TXT Allogene Modifies Lymphoma Trial After Patient Death
08/01/2025
 
 
TXT LENZ Therapeutics Get OK for Presbyopia Eye Drops
08/01/2025
 
 
TXT Illumina to Pay $9.8 Million in Cybersecurity Case
08/01/2025
 
 
TXT Draeger Recalls SafeStar 90 Plus Ventilator Filters
08/01/2025
 
 
TXT Hamilton Recalls Ventilatory Breathing Circuit Sets
07/31/2025
 
 
TXT Lilly Reports Favorable Data in Mounjaro CV Trial
07/31/2025
 
 
TXT FDA Approves SetPoint Medical Arthritis Device
07/31/2025
 
 
TXT Makary Blames NIH for Covid Virus
07/31/2025
 
 
TXT 15 Observations in Jubilant HollisterStier FDA-483
07/31/2025
 
 
TXT Cardiosense Wearable Cleared as Heart Function Monitor
07/31/2025
 
 
TXT FDA Makes ISTAND Pilot Permanent
07/31/2025
 
 
TXT Trump Overruled Makary, RFK, to Fire Prasad: Sources
07/31/2025
 
 
TXT Senate Amendment Seeks to Block Illicit Drug Imports
07/31/2025
 
 
TXT FDA Orders New Mandatory Opioid Labeling
07/31/2025
 
 
TXT MDUFA Small Business Qualification Guide
07/30/2025
 
 
TXT House Dems Hit FDA, HHS Over Vaccines
07/30/2025
 
 
TXT FDA Lays Out Unapproved GLP-1 Drug Concerns
07/30/2025
 
 
TXT FDA Ends Arthritis Advisory Committee
07/30/2025
 
 
TXT Speed Access to Drugs and Cut Drug Use: Makary
07/30/2025
 
 
TXT CBER Chief Prasad Fired, FDA ‘Gold Standard’ Out Too?
07/30/2025
 
 
TXT J&J Seeks Label Update on Tremfya
07/29/2025
 
 
TXT FDA Ratchets Up Heat on 7-OH Products
07/29/2025
 
 
TXT Shiva Contract Lab CGMP Violations
07/29/2025
 
 
TXT Quality Management Benefits Exceed Costs: FDA Paper
07/29/2025
 
 
TXT Antibacterial Therapies Q&A Guidance
07/29/2025
 
 
TXT User Fee Rates Set for FY 2026
07/29/2025
 
 
TXT Multiple Violations at Onkos Surgical
07/29/2025
 
 
TXT CGMP Deviations in Macsen Drugs Inspection
07/29/2025
 
 
TXT Recognify Reports Mixed Data on Schizophrenia Drug
07/28/2025
 
 
TXT Input Sought on Controversial Menopause Expert Panel
07/28/2025
 
 
TXT FDA Probes New Death of Boy Who Got Elevidys
07/28/2025
 
 
TXT Roche Reports Positive Data on Alzheimer’s Drug
07/28/2025
 
 
TXT House Reps Urge FDA Action on Counterfeit Obesity Drugs
07/28/2025
 
 
TXT FDA Relents, Allows Gene Therapy Limited Use
07/28/2025
 
 
TXT FDA Clears Stereotaxis MAGiC Sweep Catheter
07/28/2025
 
 
TXT Makary Defends CBER’s Prasad After Loomer Attack
07/25/2025
 
 
TXT FDA Extends Review of Bayer Menopause Drug
07/25/2025
 
 
TXT FDA/ASCO Unite on Oncology Optimal Dosing
07/25/2025
 
 
TXT FDA Alert on Benzene Contamination in Products
07/25/2025
 
 
TXT Ethicon Endo-Surgery Recalls Echelon Vascular Stapler
07/25/2025
 
 
TXT Medline Recalls Craniotomy Kits
07/24/2025
 
 
TXT FDA Priority Review for Sprout’s Addyi sNDA
07/24/2025
 
 
TXT FDA to Demand New Elevidys Safety Data from Sarepta
07/24/2025
 
 
TXT Abivax Favorable Data in Ulcerative Colitis Trials
07/24/2025
 
 
TXT Bill to Require Drug Price in DTC Ads
07/24/2025
 
 
TXT Gilead Sciences Settlement Helps 49 States
07/24/2025
 
 
TXT Stakeholder Suggestions for PDUFA Reauthorization
07/24/2025
 
 
TXT RFK Jr. OK’s Directive to Ban Thimerosal in Flu Shots
07/23/2025
 
 
TXT FDA Soliciting CNPV Pilot Interest
07/23/2025
 
 
TXT Few ODAC Advisory Committee Questions Difficult: Study
07/23/2025
 
 
TXT FDA SSDC White Paper Out
07/23/2025
 
 
TXT FDA Extends Review of GSK Multiple Myeloma BLA
07/23/2025
 
 
TXT FDA’s Elsa ‘Hallucinates Confidently’: Report
07/23/2025
 
 
TXT Baxter Recalls Mobile Lift Component
07/23/2025
 
 
TXT FDA: Multiple Violations at O3UV
07/22/2025
 
 
TXT CGMP Violations at Glenmark Unit
07/22/2025
 
 
TXT FDA Rejects Replimune BLA for Melanoma Therapy
07/22/2025
 
 
TXT FDA Wins as Sarepta Folds and Stops Shipping Elevidys
07/22/2025
 
 
TXT Lax GLP-1 Compounding Regulation Hurts Patients: Report
07/22/2025
 
 
TXT Laura Loomer Urges Ouster of CBER Head Prasad
07/22/2025
 
 
TXT Longer Drug Review Time Means Fewer Approvals: CBO
07/22/2025
 
 
TXT FDA Alert on Baxter’s Infusion Pump
07/22/2025
 
 
TXT Official Action Indicated Rare in GCP Inspections: Report
07/22/2025
 
 
TXT J&J Seeks Approval for Oral Peptide for Psoriasis
07/21/2025
 
 
TXT Industry Vet and Academic Tidmarsh Named CDER Head
07/21/2025
 
 
TXT Integra Recalls MicroMyst Applicators
07/21/2025
 
 
TXT Sarepta Disregards FDA Request to Stop Shipping Elevidys
07/21/2025
 
 
TXT Roche Reports Mixed Data on COPD Studies
07/21/2025
 
 
TXT Maquet Servo Ventilators in Class 1 Recall
07/21/2025
 
 
TXT FDA Mulls Pulling Sarepta’s Gene Therapy
07/18/2025
 
 
TXT Guide on Biosimilar Formal Meeting Requsts
07/18/2025
 
 
TXT SunMed Manual Resuscitators Recalled
07/18/2025
 
 
TXT Sen. Durbin Calls for Crackdown on DTC Telehealth
07/18/2025
 
 
TXT FDA Rejects Genentech’s Bid to Expand Columvi Use
07/18/2025
 
 
TXT Panel Votes Down Rexulti for PTSD
07/18/2025
 
 
TXT FDA AI Moves Raise Questions: Attorneys
07/17/2025
 
 
TXT Panel Votes Down GSK Multiple Myeloma Drug
07/17/2025
 
 
TXT Dexcom Recalls Dexcom Glucose Monitor Receivers
07/17/2025
 
 
TXT Investigate GLP-1 Online Marketing: Blackburn
07/17/2025
 
 
TXT CDER Losing Staff ‘In Droves’: Report
07/17/2025
 
 
TXT pCR May Not be Valid Rectal Cancer Endpoint: Study
07/17/2025
 
 
TXT FDA Looking to Expand Project Orbis Outside Oncology
07/17/2025
 
 
TXT FDA Warns Firm Marketing Blood Pressure Estimator
07/16/2025
 
 
TXT Anselamimab Trial Misses Primary Endpoint in Amyloidosis
07/16/2025
 
 
TXT New Orphan Product Grant Funding Opportunity
07/16/2025
 
 
TXT 7 Observations in Natco Pharma FDA-483
07/16/2025
 
 
TXT Guide to Characterize Combination Cancer Drugs
07/16/2025
 
 
TXT Reviewers Question Otsuka PTSD Drug Efficacy
07/16/2025
 
 
TXT Partial Hold on Kezar’s Zetomipzomib Lifted
07/16/2025
 
 
TXT Caranx AI Valve Replacement Software Cleared
07/16/2025
 
 
TXT HHS Finalizes FDA Employee Terminations
07/15/2025
 
 
TXT CGMP Violations Cited in Daewoo Warning
07/15/2025
 
 
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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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