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FDA-RELATED NEWS
 
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TXT Promising Ianalumab Data for Thrombocytopenia: Novartis
08/12/2025
 
 
TXT Elsa Hallucinations ‘Not A Surprise’: AI Expert
08/12/2025
 
 
TXT Get Strategic Intelligence from Device Warnings
08/12/2025
 
 
TXT He’s Back: Makary Rehires Prasad as CBER Head
08/11/2025
 
 
TXT Novartis to Seek Approval for Sjögren’s Disease Drug
08/11/2025
 
 
TXT GSK sNDA for Oral Gonorrhoea Treatmemt
08/11/2025
 
 
TXT IO Biotech’s Cancer Vaccine Misses Trial ‘Significance’
08/11/2025
 
 
TXT Nyxoah’s Genio Device OK’d for Sleep Apnea
08/11/2025
 
 
TXT FDA Hits Dr. Reddy’s Plant with 7-Item 483
08/11/2025
 
 
TXT NDA Filed for PROTAC Therapy in Breast Cancer
08/11/2025
 
 
TXT FDA Orders Stricter Safety Labeling for Skysona
08/08/2025
 
 
TXT Sodium Chloride Drug Shortage Resolved: Makary
08/08/2025
 
 
TXT BD Recalls BD Alaris Pump Software
08/08/2025
 
 
TXT Accelerated OK for Boehringer Lung Cancer Drug
08/08/2025
 
 
TXT FDA Ramps Up Global Drug Quality Oversight
08/08/2025
 
 
TXT FDA Steps to Boost U.S. Drug Production
08/07/2025
 
 
TXT ICH Extractables, Leachables Guide
08/07/2025
 
 
TXT Julie Tierney Joins Leavitt Partners
08/07/2025
 
 
TXT J&J Complete Response Letter on Darzalex Faspro
08/07/2025
 
 
TXT Instylla PMA Approved for Hypervascular Tumors
08/07/2025
 
 
TXT FDA Acting Against Unapproved Thyroid Meds
08/07/2025
 
 
TXT Lilly Plans NDA for Oral Weight-Loss Drug
08/07/2025
 
 
TXT FDA Early Alert on Watchman Devices
08/06/2025
 
 
TXT Quarantine Some Medline ReNewal Catheters
08/06/2025
 
 
TXT FDA Accelerated Approval for Jazz Modeyso
08/06/2025
 
 
TXT QS, MDR Issues at Taiwan’s Visgeneer
08/06/2025
 
 
TXT Medical Device PFAS Appear Safe: FDA
08/06/2025
 
 
TXT BMS Files Breyanzi Marginal Zone Lymphoma sBLA
08/06/2025
 
 
TXT CGMP Violations at Oasis Medical
08/05/2025
 
 
TXT Laura Loomer Targets Makary Over Prasad Exit
08/05/2025
 
 
TXT Former FDA Staff Chief Joins Hogan Lowells
08/05/2025
 
 
TXT Vertex Signal Inhibitor VX-993 Misses Trial Goal
08/05/2025
 
 
TXT FDA Publishes Data Standards Program Update
08/05/2025
 
 
TXT Mectronic Medicale Multiple Violations
08/05/2025
 
 
TXT Two-Day Workshop on Oncology Patient Registries
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 Multiple Violations at Onkos Surgical
07/29/2025
 
 
TXT CGMP Deviations in Macsen Drugs Inspection
07/29/2025
 
 
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 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 FDA Alert on Benzene Contamination in Products
07/25/2025
 
 
TXT Ethicon Endo-Surgery Recalls Echelon Vascular Stapler
07/25/2025
 
 
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 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 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 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 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 FDA: Multiple Violations at O3UV
07/22/2025
 
 
TXT CGMP Violations at Glenmark Unit
07/22/2025
 
 
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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:
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