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FDA-RELATED NEWS
 
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TXT FDA Touts CDER Advanced Manufacturing Research Facility
08/15/2024
 
 
TXT Priority Review for Imfinzi sBLA in Lung Cancer
08/15/2024
 
 
TXT NexoBrid Gets Expanded Use for Pediatric Burns
08/15/2024
 
 
TXT Stakeholders Comment on Advisory Committee Session
08/15/2024
 
 
TXT Changes Sought in REMS Logic Guidance
08/14/2024
 
 
TXT Prednisolone Solution Needs Stability Studies: Petition
08/14/2024
 
 
TXT Accelerated Approval for Gilead’s Livdelzi
08/14/2024
 
 
TXT FDA Approves Incyte’s Niktimvo
08/14/2024
 
 
TXT Workshop on Measuring Gonadal Toxicity
08/14/2024
 
 
TXT Big Health’s SleepioRx Cleared for Sleep Help
08/14/2024
 
 
TXT Peripheral/CNS Drugs Panel Renewed
08/13/2024
 
 
TXT ‘Objectionable Conditions’ in Doctor’s Clinical Trial
08/13/2024
 
 
TXT Nowrez & Ismail Shukri CGMP Violations
08/13/2024
 
 
TXT QS, MDR Violations at Globus Medical
08/13/2024
 
 
TXT Proprietary Name Review MAPP
08/13/2024
 
 
TXT Tandem Diabetes Insulin Pump App Recall
08/13/2024
 
 
TXT Creating Hope Reauthorization Act Introduced
08/13/2024
 
 
TXT Change Biological Drug Monographs: Petition
08/13/2024
 
 
TXT Advisors Surveyed on Committee Reforms
08/13/2024
 
 
TXT Clinical Hold Removed on Dravet Syndrome Drug
08/13/2024
 
 
TXT FDA Clears BioVie for Parkinson’s Trial
08/13/2024
 
 
TXT Abiomed Recalls Impella CP Heart Pumps
08/12/2024
 
 
TXT Kyverna Gets FDA Regenerative Medicine Status
08/12/2024
 
 
TXT Lykos to Appeal MDMA Drug Rejection
08/12/2024
 
 
TXT Ascendis Hypoparathyroidism Drug Approved
08/12/2024
 
 
TXT FDA Needs More Time on Humacyte BLA Review
08/12/2024
 
 
TXT FDA OKs Neffy Allergic Reaction Nasal Spray
08/09/2024
 
 
TXT Braun Recalls 2 Sodium Chloride Lots
08/09/2024
 
 
TXT Cardiologist to Lead Digital Health Panel
08/09/2024
 
 
TXT Guide BCG-Unresponsive Bladder Cancer Drugs
08/09/2024
 
 
TXT Hold Lifted on Fabry Cardiomyopathy Therapy
08/09/2024
 
 
TXT 4 Observations on Imprimis FDA-483
08/08/2024
 
 
TXT Stakeholder Comments on FDA BIMO Guidance
08/08/2024
 
 
TXT Oncologic Drug Dosage Guidance
08/08/2024
 
 
TXT Amneal Gets Approval for Parkinson’s Drug
08/08/2024
 
 
TXT Drug Experiential Learning Site Visits for FY 2025
08/08/2024
 
 
TXT Huxley Gains Clearance for At-Home Apnea Test
08/08/2024
 
 
TXT BCG Treatment Development Guidance
08/08/2024
 
 
TXT FDA Approves Medtronic Simplera Monitor
08/07/2024
 
 
TXT Panel to Review Urinary Tract Infection NDA
08/07/2024
 
 
TXT FDA to Survey Healthcare Providers
08/07/2024
 
 
TXT Servier Gets OK for Brain Tumor Drug
08/07/2024
 
 
TXT Data Integrity is Biggest Inspection Issue: FDA
08/07/2024
 
 
TXT Enforce Regulation of ‘Wellness’ Devices: Petition
08/07/2024
 
 
TXT FDA Cites Krazati Provider Web Page
08/07/2024
 
 
TXT BeiGene’s Tevimbra First-Line Use ‘Deferred’
08/07/2024
 
 
TXT Wegovy sNDA for Heart Failure Withdrawn
08/07/2024
 
 
TXT Court Should Deny Novartis Injunction Request: FDA
08/07/2024
 
 
TXT FDA accepts Cabometyx sNDA for Pancreatic Tumors
08/06/2024
 
 
TXT CDRH Health Equity Discussion Paper
08/06/2024
 
 
TXT Bill Introduced to Spur Pediatric Rare Disease Studies
08/06/2024
 
 
TXT Smith’s Medical Software Correction for Infusion Pumps
08/06/2024
 
 
TXT Loper Bright May End FDA Speech Ban: Attorney
08/06/2024
 
 
TXT Velocity Marketed Adulterated Eye Drops: FDA
08/06/2024
 
 
TXT CGMP Violations at Guangzhou Baiyunshan
08/06/2024
 
 
TXT Enhancing Diversity in Pediatric Drug Development Workshop
08/06/2024
 
 
TXT Man Sentenced for Misbranded Drugs
08/06/2024
 
 
TXT Reclassify Some Oncology Panels: Petition
08/06/2024
 
 
TXT Petition Seeks Gov’t Action to Allow Generic Semaglutide
08/05/2024
 
 
TXT Drug Safety Committee Renewed
08/05/2024
 
 
TXT Labcorp Gets De Novo for Tumor Assay
08/05/2024
 
 
TXT Exactech Joint Replacement Device Recall Updated
08/05/2024
 
 
TXT Rare Disease Status for Hyperoxaluria Drug: META
08/05/2024
 
 
TXT Another Study Needed for Iomab-B BLA: FDA
08/05/2024
 
 
TXT Inspire’s Sleep Apnea Neurostimulator Approved
08/02/2024
 
 
TXT Gene Therapy for Synovia Sarcoma Approved
08/02/2024
 
 
TXT Orphan Status for Cellectis Leukemia Therapy
08/02/2024
 
 
TXT DePuy Robotic Knee Replacement Cleared
08/02/2024
 
 
TXT Octapharma’s Fibryga OK’s for Expanded Use
08/02/2024
 
 
TXT Psychopharmacologic Drugs Panel Renewal
08/01/2024
 
 
TXT FDA Explains New LabelComp Tool
08/01/2024
 
 
TXT FDA OKs Expanded Jemperli Indication
08/01/2024
 
 
TXT Abbott Device Correction on FreeStyle Libre 3
08/01/2024
 
 
TXT Novartis Sues FDA to Reverse Generic Entresto OK
08/01/2024
 
 
TXT Telix Pharma Hit with Refuse-to-File on BLA
08/01/2024
 
 
TXT Updated CDER Guidance Agenda
08/01/2024
 
 
TXT M12 Drug Interaction Q&A
08/01/2024
 
 
TXT Durbin, Cassidy Introduce Drug Competition Bill
08/01/2024
 
 
TXT Stakeholder Comments on Cell, Gene Guidance
07/31/2024
 
 
TXT FDA Publishes ICH Bioequivalence Guidance
07/31/2024
 
 
TXT FDA May Allow Novel Carve-Ins: Attorneys
07/31/2024
 
 
TXT Man Indicted for Selling Counterfeit Cancer Drugs
07/31/2024
 
 
TXT New Quantitative Medicine CoE Resources
07/31/2024
 
 
TXT OTC Monograph FY 2025 User Fee Rates
07/31/2024
 
 
TXT CDER Used AI/ML in Kineret EUA
07/31/2024
 
 
TXT Alert on Megadyne Patient Return Electrodes
07/31/2024
 
 
TXT Ways to Improve OS Data Collection, Analysis
07/31/2024
 
 
TXT Medical Device User Fee Rates
07/30/2024
 
 
TXT Prescription Drug User Fee Rates Set
07/30/2024
 
 
TXT Amco Illegally Selling AED Batteries: FDA
07/30/2024
 
 
TXT OSE Involved in 55 Novel Drug Approvals
07/30/2024
 
 
TXT Vertex NDA for Pain Drug Accepted for Review
07/30/2024
 
 
TXT Require Nasal Spray Food Studies: Aquestive
07/30/2024
 
 
TXT Amazon, Walmart Illegally Sell Chemical Peels
07/30/2024
 
 
TXT FDA Denies Public Citizen Tramadol Petition
07/30/2024
 
 
TXT Novartis sNDA for Scemblix Expanded Use
07/30/2024
 
 
TXT Syndax Leukemia Review Extended by FDA
07/29/2024
 
 
TXT Colon Cancer Blood Test Approved
07/29/2024
 
 
TXT AstraZeneca Reports Favorable Calquence Data
07/29/2024
 
 
TXT Kaleo Social Media Post Runs Afoul of FDA
07/29/2024
 
 
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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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