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FDA-RELATED NEWS
 
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TXT Clinical Researchers Plead Guilty to Fraud
03/11/2025
 
 
TXT FDA Warns 6 Firms on Unapproved Fat-Dissolving Drugs
03/11/2025
 
 
TXT Beckman Coulter 510(k) Cleared for Clinical Analyzer
03/11/2025
 
 
TXT Top Device Science Official Leaves FDA
03/11/2025
 
 
TXT Glenmark Pharma Hit With 483 After India Inspection
03/10/2025
 
 
TXT FDA Taps Jim Traficant as Chief of Staff
03/10/2025
 
 
TXT Mineralys Nets Positive Data in Hypertension Drug Studies
03/10/2025
 
 
TXT Dexcom Hit With Warning After 2 Inspection
03/10/2025
 
 
TXT FDA Staff Given $25,000 Buyout Offers
03/10/2025
 
 
TXT FDA Clears Zimmer Persona Knee Implant
03/07/2025
 
 
TXT Fresenius Kabi Recalls Ivenix Infusion Software
03/07/2025
 
 
TXT J&J Stops Phase 3 Depression Drug Program
03/07/2025
 
 
TXT FDA Domestic Inspections Fall, Foreign Rise: Study
03/07/2025
 
 
TXT Celltrion BLA for Interchangeable Xolair Biosimilar
03/07/2025
 
 
TXT FDA Nixes Vanda Hetlioz Hearing
03/06/2025
 
 
TXT Nuwellis AquaFlexFlow Recall is Class 1
03/06/2025
 
 
TXT FDA OKs Gene Therapy for Retinal Disease
03/06/2025
 
 
TXT Micro Therapeutics Recalls Embolization Device
03/06/2025
 
 
TXT Opportunities for Drug Development Dynamic Tools
03/06/2025
 
 
TXT 2 FDA Designations for Phantom Neuro Platform
03/06/2025
 
 
TXT Makary Pledges FDA Staff Assessment Due to Firings
03/06/2025
 
 
TXT Baxter Infusion Pump Issue Early Alert
03/05/2025
 
 
TXT Orphan Drug Designation for Faron’s Bexmarilimab
03/05/2025
 
 
TXT Roche Files sBLA for Gazyva in Lupus
03/05/2025
 
 
TXT Indian-Made Generics Have Higher Risk: Study
03/05/2025
 
 
TXT FDA Clinical Hold on BioNTech Malaria Vaccine
03/05/2025
 
 
TXT CGMP Violations at Granules India Limited
03/04/2025
 
 
TXT Comments on Protocol Deviations Guidance
03/04/2025
 
 
TXT Makary To Divest Extensive Holdings: Ethics Report
03/04/2025
 
 
TXT Chem-Tech Inspection Violations
03/04/2025
 
 
TXT Capricor BLA for Duchenne-related Cardiomyopathy
03/04/2025
 
 
TXT Celltrion’s Prolia and Xgeva Biosimilars Approved
03/04/2025
 
 
TXT Regulated Companies Fear FDA Cuts Impact
03/04/2025
 
 
TXT Musk’s DOGE Cancels Leases on 30 FDA Field Offices
03/04/2025
 
 
TXT OPDP Hits Edenbridge Pharma Over Promos
03/04/2025
 
 
TXT Corcept Files NDA for Cushing’s Syndrome Drug
03/03/2025
 
 
TXT Rusfertide Phase 3 Data Meet Endpoints
03/03/2025
 
 
TXT Lexicon Taps Pilavapadin 10mg for Phase 3
03/03/2025
 
 
TXT PharmaTher Resubmits Ketamine NDA
03/03/2025
 
 
TXT Boston Scientific Recalls Pacemakers
03/03/2025
 
 
TXT Philips Recalls Tack Endovascular Device
03/03/2025
 
 
TXT PhRMA Seeks Changes to Protocol Deviations Guide
03/03/2025
 
 
TXT Olympus Recalls Endoscope Guide Sheaths
02/28/2025
 
 
TXT Labeling Changes for Testosterone Products: FDA
02/28/2025
 
 
TXT Lawyers Say Government Shutdown Could Stall Reviews
02/28/2025
 
 
TXT Zevra Selling Priority Voucher for $150 Million
02/28/2025
 
 
TXT ROi CPS Recalls Newborn Kits
02/28/2025
 
 
TXT Praxis to Finish Study Despite Data Miss
02/28/2025
 
 
TXT Bill to Block LDT Regulation
02/27/2025
 
 
TXT FDA Warns India’s Granules Generic Drug Company
02/27/2025
 
 
TXT Ventec Recalls VOCSN Ventilators
02/27/2025
 
 
TXT Makary FDA Confirmation Hearing Set for 3/6
02/27/2025
 
 
TXT FDA Suddenly Cancels Crucial Flu Vaccine Meeting
02/27/2025
 
 
TXT Fast-Track for Adicet Systemic Sclerosis Drug
02/27/2025
 
 
TXT 19-Page Exela Pharma Sciences FDA-483
02/27/2025
 
 
TXT 7 Observations in Zhejiang Huahai FDA-483
02/27/2025
 
 
TXT 6 Observations on Piramal Pharma FDA-483
02/26/2025
 
 
TXT Indoco Remedies FDA-483 Released
02/26/2025
 
 
TXT Camizestrant in Breast Cancer Meets Primary Endpoint
02/26/2025
 
 
TXT Google Watch Cleared for ‘Pulse Loss’ Detection
02/26/2025
 
 
TXT CDER Touts FY 2024 Drug Safety Activities
02/26/2025
 
 
TXT 16% Oncology Phase 2 Patients Get Drugs Later OKd
02/26/2025
 
 
TXT Regeneron Refiles BLA for Follicular Lymphoma
02/26/2025
 
 
TXT Generic Mifepristone Maker Wants to Defend Suit
02/26/2025
 
 
TXT More FDA Cuts Coming Down the Road
02/26/2025
 
 
TXT OTC Shampoo Suit Preempted by FDA Monograph
02/25/2025
 
 
TXT Janssen Vaccines FDA-483
02/25/2025
 
 
TXT Detailed Comments on Protocol Deviations Draft Guide
02/25/2025
 
 
TXT Fertility Center of California HCT/P Deviations
02/25/2025
 
 
TXT Priority Review for Keytruda Head/Neck Cancer sBLA
02/25/2025
 
 
TXT FDA Removes Clozapine REMS Program
02/25/2025
 
 
TXT 4 Observations on AstraZeneca FDA-483
02/25/2025
 
 
TXT Emalex’ Ecopipam Meets Tourette Study Endpoints
02/25/2025
 
 
TXT Tandem Diabetes Insulin Algorithm Cleared for Type 2
02/25/2025
 
 
TXT Contaminated SinuCleanse Nasal Wash Recalled
02/25/2025
 
 
TXT Entrada Clinical Hold Lifted on Duchenne Drug
02/24/2025
 
 
TXT Ex-CDER Head Cavazzoni Rejoins Pfizer
02/24/2025
 
 
TXT Medtronic’s Brain Stimulator for Parkinson’s Approved
02/24/2025
 
 
TXT FDA Trying to Rehire 300 Staff Recently Fired
02/24/2025
 
 
TXT BMS Files sBLA for Opdivo+Yervoy in Colon Cancer
02/24/2025
 
 
TXT Compounders Sue FDA Over Semaglutide Shortages
02/24/2025
 
 
TXT Wegovy, Ozempic Shortages Resolved: FDA
02/21/2025
 
 
TXT Pfizer Drops Hemophilia B Gene Therapy
02/21/2025
 
 
TXT Boehringer NDA for Lung Cancer
02/21/2025
 
 
TXT Mirum’s Ctexli Approved for Rare Lipid Disease
02/21/2025
 
 
TXT PhRMA Suggests Revisions to Cell Therapy Guide
02/21/2025
 
 
TXT FDA Staff Exodus Deepens as CBER Deputy Witten Quits
02/21/2025
 
 
TXT Increased Foreign Company Enforcement Likely: Attorneys
02/20/2025
 
 
TXT Robert Foster Named FDA Chief Counsel
02/20/2025
 
 
TXT Did Trump Ban ‘Woman’ and ‘Disabled’ at FDA?
02/20/2025
 
 
TXT LDT Court Ruling As Soon As Possible, Judge Says
02/20/2025
 
 
TXT Bill for Canadian Drug Imports Reintroduced
02/20/2025
 
 
TXT 2024 Device Recalls Up, Drug Recalls Down: Sedgwick
02/19/2025
 
 
TXT Expanded Access to TICE BCG Substitute
02/19/2025
 
 
TXT What Happens to FDA in a Budget Shutdown?
02/19/2025
 
 
TXT AdvaMed Urges HHS Reversal of FDA Staff Cuts
02/19/2025
 
 
TXT FDA Refusal to File Wakix sNDA
02/19/2025
 
 
TXT AGs Seek FDA Actions on Counterfeit GLP-1 Drugs
02/19/2025
 
 
TXT Multiple Violations at Jagsonpal Pharmaceuticals
02/18/2025
 
 
TXT CGMP Deviations at Tyche Industries
02/18/2025
 
 
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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:
  • 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;
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