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FDA-RELATED NEWS
 
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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
 
 
TXT Publish Guidance on Robotic Mastectomy: Petition
02/18/2025
 
 
TXT Top Five 2024 FDA Data Quality Issues
02/18/2025
 
 
TXT Hundreds of FDA Employees Get Termination Letters
02/18/2025
 
 
TXT AlgoTx Will Continue ATX01 15% Development
02/18/2025
 
 
TXT Suspend/Revoke all Covid mRNA Vaccines: Petition
02/18/2025
 
 
TXT FDA Gladiator: Larry R. Pilot (1940-2025)
02/18/2025
 
 
TXT ICU Medical Recalls Potassium Chloride Lot
02/14/2025
 
 
TXT New Endpoint Option for Alcohol Use Disorder
02/14/2025
 
 
TXT Clinical Hold on Moderna Norovirus Vaccine
02/14/2025
 
 
TXT FDA OKs Sanofi’s Merilog, a Novolog Biosimilar
02/14/2025
 
 
TXT Abiomed Recalls Impella Heart Pumps
02/14/2025
 
 
TXT Gender Statement Added to Restored FDA Pages
02/14/2025
 
 
TXT BMS Reports Disappointing Data in Melanoma Trial
02/14/2025
 
 
TXT More Accelerated Approval Changes Needed: Kaiser
02/13/2025
 
 
TXT Petition Seeks FDA Leukeran Actions
02/13/2025
 
 
TXT Endo Wants Generic Epinephrine Restrictions
02/13/2025
 
 
TXT Vaccine Skeptic Kennedy Confirmed as HHS Secretary
02/13/2025
 
 
TXT Study Sees New Trazodone Adverse Events
02/13/2025
 
 
TXT FDA Still Faster than EMA on Cancer Approvals
02/13/2025
 
 
TXT Sanofi/J&J Scrap E. Coli Vaccine Candidate
02/13/2025
 
 
TXT Court Rules for FDA in Vanda Label Case
02/13/2025
 
 
TXT Travere Therapeutics Plans Filspari sNDA
02/12/2025
 
 
TXT Bioresearch Monitoring Issue at ISOThrive
02/12/2025
 
 
TXT CGMP Deviations at Wuhu Nuowei Chemistry
02/12/2025
 
 
TXT Olympus Recalls Bronchoscope Guide Sheaths
02/12/2025
 
 
TXT DoJ Probing Inspire Marketing, Reimbursement
02/12/2025
 
 
TXT FDA Clarifies Compounded GLP-1 Enforcement
02/12/2025
 
 
TXT Regeneron BLA Resubmitted for Multiple Myeloma
02/11/2025
 
 
TXT Change FDA AI Policies: Gottlieb
02/11/2025
 
 
TXT Strukmyer Medical CGMP Violations
02/11/2025
 
 
TXT Chengdu Records Review Finds CGMP Deviations
02/11/2025
 
 
TXT Court Orders FDA to Restore ‘Gender’ Web Pages
02/11/2025
 
 
TXT Change FDA Approach to Antibiotic Approval: Column
02/11/2025
 
 
TXT Breakthrough Status for Knee Arthritis Device
02/11/2025
 
 
TXT CA Man Sentenced Over Unapproved Drugs
02/10/2025
 
 
TXT Sentec/Percussionaire Breathing Circuit Recalled
02/10/2025
 
 
TXT Pliant Pauses Bexotegrast Trial for Safety Review
02/10/2025
 
 
TXT Guide on IRB Written Procedures
02/10/2025
 
 
TXT Boehringer Ingelheim Plans NDA for Lung Disease
02/10/2025
 
 
TXT Tempest Gets Fast Track for Amezalpat
02/10/2025
 
 
TXT Roche Shares Positive Data on Gazyva
02/07/2025
 
 
TXT Lawmakers Urge FDA to Block Super Bowl Drug Ad
02/07/2025
 
 
TXT Adicet Wins Fast Track for Lupus Cell Therapy
02/07/2025
 
 
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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;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving