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FDA-RELATED NEWS
 
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TXT Innate Healthcare Illegally Marketing Stem Cells: FDA
08/27/2025
 
 
TXT Violations in Uscom Spirometer Inspection
08/27/2025
 
 
TXT 11 QS, MDR Violations at Miach Orthopaedics
08/26/2025
 
 
TXT BIO September Congressional Priorities
08/26/2025
 
 
TXT Multiple GLP Violations at China’s Jiangsu Kerbio
08/26/2025
 
 
TXT FDA Breakthrough Status for Lupis Blood Purifier
08/26/2025
 
 
TXT Lilly Plans NDA for Obesity Pill; Positive Data Released
08/26/2025
 
 
TXT QS Violations at LeMaitre Vascular
08/26/2025
 
 
TXT Allarity’s Stenoparib on FDA Fast Track
08/26/2025
 
 
TXT Axogen Nerve Graft Review Extended by 3 Months
08/26/2025
 
 
TXT Breakthrough Status for Quest’s Haystack MRD Test
08/25/2025
 
 
TXT Alert on Hyperbaric Oxygen Devices
08/25/2025
 
 
TXT FDA Broadens Use of Amgen’s Repatha
08/25/2025
 
 
TXT Chikungunya Vaccine Suspended Due to Safety Concerns
08/25/2025
 
 
TXT FDA Study: CBD Linked to Elevated Liver Enzymes
08/25/2025
 
 
TXT Vanda Urges Makary to Intercede in Generic Dispute
08/22/2025
 
 
TXT AdvaMed Urges FDA/CMS Alignment on Breakthrough Devices
08/22/2025
 
 
TXT Boston Scientific Recalls Defective Stent System
08/22/2025
 
 
TXT FDA 483 Shows GMP Troubles at Plant Making Eylea
08/22/2025
 
 
TXT FDA Moves to Daily Drug Adverse Event Data
08/22/2025
 
 
TXT Stealth Gets Expedited Review on NDA Resubmission
08/21/2025
 
 
TXT Gaps Seen in Dementia AI Device Transparency
08/21/2025
 
 
TXT Rinvoq Meets Endpoints in Alopecia Trial
08/21/2025
 
 
TXT 21% of FDA Staff Gone: Analysis
08/21/2025
 
 
TXT 14 States Join Mifepristone Petition to FDA
08/21/2025
 
 
TXT Device Dental Bone Graft Study Guidance
08/21/2025
 
 
TXT Oncology Trial Overall Survival Assessment Guide
08/21/2025
 
 
TXT Workshop on Allergic Dermatitis Patch Test Alternatives
08/20/2025
 
 
TXT Nucleus RadioPharma Names Former FDA Head as CEO
08/20/2025
 
 
TXT FDA Rejects enVVeno Medical Venous Valve PMA
08/20/2025
 
 
TXT FDA Lifts Hold on Rocket’s Gene Therapy
08/20/2025
 
 
TXT Impact of FDA China Cell Rule Unclear: Experts
08/20/2025
 
 
TXT Stop Inaccurate Health Info: HHS Staff to RFK, Jr.
08/20/2025
 
 
TXT FDA Updates Breakthrough Device Statistics
08/20/2025
 
 
TXT FDA DrugSorb-ATR Options
08/20/2025
 
 
TXT Act Against Compounded Semaglutide: Petition
08/20/2025
 
 
TXT 2 Eylea HD Submissions Get Review Extensions
08/20/2025
 
 
TXT Multiple Les Encres Violations
08/19/2025
 
 
TXT CGMP Violations Seen in Anhui Hanbon Inspection
08/19/2025
 
 
TXT FDA Pushes Back Review of Hunter Syndrome BLA
08/19/2025
 
 
TXT PTC Therapeutics’ Friedreich’s Ataxia Drug Rejected
08/19/2025
 
 
TXT Clinical Hold on BiomX Cystic Fibrosis Therapy
08/19/2025
 
 
TXT Viking Reports Mixed Data on Obesity Drug
08/19/2025
 
 
TXT AI-DSF Change Control Plan Guidance
08/19/2025
 
 
TXT FDA Denies Ferring Reconsideration Petition
08/19/2025
 
 
TXT Test and Report Leachable Nitrosamines: FDA
08/19/2025
 
 
TXT NeuroOne’s Trigeminal Nerve Ablation Cleared
08/19/2025
 
 
TXT Cancer Radiopharm. Dosage Guide
08/18/2025
 
 
TXT Stealth Refiles NDA for Barth Syndrome Drug
08/18/2025
 
 
TXT Court Orders FDA to Reconsider Vanda sNDA
08/18/2025
 
 
TXT Advisory Panel Conflicts of Interest Low: Study
08/18/2025
 
 
TXT Tandem Recalls Insulin Pumps Due to Alarm Error
08/18/2025
 
 
TXT Wegovoy OK’d for Metabolic Steatohepatitis
08/18/2025
 
 
TXT FDA Delays Clinical Hold Review on Neurizon ALS Drug
08/15/2025
 
 
TXT FDA Alert on Baxter Novum Infusion Pumps
08/15/2025
 
 
TXT Omeros BLA for Narsoplimab Gets Review Extension
08/15/2025
 
 
TXT FDA OKs Papzimeos for Respiratory Papillomatosis
08/15/2025
 
 
TXT Sickle Cell Drug Misses Phase 3 Endpoint: Pfizer
08/15/2025
 
 
TXT BEAM-101 Gets Advanced Therapy Designation
08/14/2025
 
 
TXT Group Pushes MDMA-Assisted Therapy for PTSD
08/14/2025
 
 
TXT Trump Orders Strategic Reserve of APIs
08/14/2025
 
 
TXT Schrödinger Nixes Leukemia Drug After 2 Deaths
08/14/2025
 
 
TXT Restrictions Asked for Ozempic ANDAs
08/14/2025
 
 
TXT CDER Equal Voice MAPP
08/14/2025
 
 
TXT HHS Revives Task Force on Safer Child Vaccines
08/14/2025
 
 
TXT Thoratec Recalls HeartMate Mobile AC Power Cord
08/14/2025
 
 
TXT Texas Sues Lilly Over ‘Illegal Kickbacks’
08/13/2025
 
 
TXT 2 Charged for Misbranded Imported Drugs
08/13/2025
 
 
TXT De Novo OK for ArteraAI Prostate Software
08/13/2025
 
 
TXT HHS Touts Pharmacy on Demand Project
08/13/2025
 
 
TXT FDAer Quits, Flips Off Trump/Vance in Viral Post
08/13/2025
 
 
TXT Agency RIF Packets Cause Privacy Concerns
08/13/2025
 
 
TXT CGMP Issues at Private Label Grooming
08/12/2025
 
 
TXT Multiple Violations in Spectra Therapy Inspection
08/12/2025
 
 
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
 
 
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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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