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FDA-RELATED NEWS
 
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TXT China Stricter than U.S. in Cancer Drug Approvals: Study
04/15/2025
 
 
TXT Address Heart Failure Patient-Reported Outcome Issues
04/15/2025
 
 
TXT Recall All Humacyte Symvess Products: Petition
04/15/2025
 
 
TXT Ironwood Needs Another Apraglutide Trial: FDA
04/14/2025
 
 
TXT Pfizer Nixes Oral Weight Loss Drug Development
04/14/2025
 
 
TXT FDA Seizes Counterfeit Ozempic in Supply Chain
04/14/2025
 
 
TXT Vanda Sues FDA to Allow Off-Label Promotion
04/14/2025
 
 
TXT TEST
04/14/2025
 
 
TXT FDA Clears Bright Uro’s Urodynamics Device
04/14/2025
 
 
TXT Marks Warns of Growing Anti-Vaccine Stance
04/11/2025
 
 
TXT Self-Inject Vyvgart Hytrulo Approved
04/11/2025
 
 
TXT FDA OKs Opdivo + Yervoy in Liver Cancer
04/11/2025
 
 
TXT Sen. Paul Introduces Biosimilars Bill
04/11/2025
 
 
TXT RFK Jr. Misfires at FDA Headquarters Address
04/11/2025
 
 
TXT Daxor Files 510(k) for Next-Gen Blood Analyzer
04/11/2025
 
 
TXT Bipartisan Brain Cancer Research Bill In
04/10/2025
 
 
TXT FDA to Phase Out Some Drug Animal Testing
04/10/2025
 
 
TXT Biomedical Industry Seeks Senate Help on FDA Cuts
04/10/2025
 
 
TXT ‘Information Bottleneck’ Due to FDA Staff Cuts: Analysis
04/10/2025
 
 
TXT FDA to Allow Some Teleworking: AP
04/10/2025
 
 
TXT FDA Clears Dexcom Glucose Monitor
04/10/2025
 
 
TXT FDA Clears Intuitive Stapler for da Vinci Robot
04/10/2025
 
 
TXT Support, Suggestions for FDA Regulatory AI Guidance
04/09/2025
 
 
TXT Generic Policy Shop Cuts will Hurt ANDAs: Post
04/09/2025
 
 
TXT Coordinate HHS Drug Shortage Activities: GAO
04/09/2025
 
 
TXT FDA OKs Dropping Tryvio REMS
04/09/2025
 
 
TXT Raskin, Others Seek FDA Meeting on Cuts
04/09/2025
 
 
TXT Kessler Slams Dangerous FDA Cuts at Hearing
04/09/2025
 
 
TXT Device Approvals Slow to 10-Year Low: Report
04/09/2025
 
 
TXT User Fee Programs are in Jeopardy: FDA Watchers
04/08/2025
 
 
TXT Restrict 2 Opioid Indications: Petition
04/08/2025
 
 
TXT ZyVersa Touts Approval Path for Kidney Disorder Drug
04/08/2025
 
 
TXT FDA ‘Like Flat Earthers Taking Over NASA’: Woodcock
04/08/2025
 
 
TXT FDA OKs Opdivo/Yervoy in Colon Cancer
04/08/2025
 
 
TXT Multiple Violations at EpiCare Acquisitions
04/08/2025
 
 
TXT Laboratory-Developed Test Decision Reviewed
04/08/2025
 
 
TXT Allogene Gets 3 Fast Tracks for Cell Therapy
04/07/2025
 
 
TXT Kennedy Senate Hearing Postponed
04/07/2025
 
 
TXT Teva Files sBLA to Expand Migraine Therapy’s Use
04/07/2025
 
 
TXT Device Reviews Will Now Take Longer: Shuren
04/07/2025
 
 
TXT Amgen’s Uplizna OK’d for Immunoglobulin G4 Disease
04/04/2025
 
 
TXT Could HHS Mea Culpa Lead to FDA Rehires?
04/04/2025
 
 
TXT House Committee Hearing on Reducing FDA Inefficiencies
04/04/2025
 
 
TXT Marks: RFK Jr. Wants FDA to Support Stem-cell Treatments
04/04/2025
 
 
TXT Draeger Recalls Flex 220 Breathing Circuit
04/04/2025
 
 
TXT CRL for Aldeyra’s Reproxalap for Dry Eye
04/03/2025
 
 
TXT Reorganization Will Block Information Flow
04/03/2025
 
 
TXT Makary Will Face Political Interference Soon: Gottlieb
04/03/2025
 
 
TXT BeiGene Drops Ociperlimab Development in Lung Cancer
04/03/2025
 
 
TXT Accelerated Approval Faces Scrutiny After Cancer Drug Review
04/03/2025
 
 
TXT Biogen Gets Fast Track for Alzheimer’s Therapy
04/02/2025
 
 
TXT Can FDA “Do More With Less?”: McClellan
04/02/2025
 
 
TXT Industry Sounds the Alarm on FDA Staff Cuts
04/02/2025
 
 
TXT Ocrevus IV Phase 3 Study Misses Primary Endpoint
04/02/2025
 
 
TXT Positive EDG-7500 Heart Drug Phase 2 Results
04/02/2025
 
 
TXT RFK Jr. Invited to Senate Hearing on HHS Reorganization
04/02/2025
 
 
TXT FDA Misses Novavax Covid Vaccine Review Action
04/02/2025
 
 
TXT FDA Remaking Inspection Priorities in Wake of Trump Cuts
04/02/2025
 
 
TXT FDA Says Rex Implants Illegally Marketing Devices
04/01/2025
 
 
TXT Bausch + Lomb Recalls enVista Intraocular Lenses
04/01/2025
 
 
TXT Axsome Solriamfetol Misses Primary Endpoint
04/01/2025
 
 
TXT 3 Observations on SKNV Outsourcing FDA-483
04/01/2025
 
 
TXT Multiple Violations in Next Science Inspection
04/01/2025
 
 
TXT FDA in Upheaval as Staff Layoffs Begin
04/01/2025
 
 
TXT RFK Jr. Upends His Promise to Enhance Transparency
04/01/2025
 
 
TXT Vanda Files NDA for Antipsychotic Drug
03/31/2025
 
 
TXT Trump Order Stifles Union Representation at FDA
03/31/2025
 
 
TXT Merck Touts Data in Pulmonary Arterial Hypertension
03/31/2025
 
 
TXT FDA Loses on Regulating Lab-Developed Tests
03/31/2025
 
 
TXT Medtronic Recalls Aortic Root Cannulas
03/31/2025
 
 
TXT Smallpox/Mpox Vaccine OK’d Despite CBER Turmoil
03/31/2025
 
 
TXT Milestone Misses Approval on Irregular Heart Beat NDA
03/28/2025
 
 
TXT FDA Green Lights At-Home Sexual Disease Test
03/28/2025
 
 
TXT Novartis Wins Expanded Pluvicto Use in Prostate Cancer
03/28/2025
 
 
TXT FDA Probes Data Integrity Concerns at India CRO
03/28/2025
 
 
TXT Sanofi’s New Hemophila Drug Approved
03/28/2025
 
 
TXT Advocates Blast Hiring ‘Quack’ for Autism Study
03/27/2025
 
 
TXT Bipartisan Patent Coordination Bill In
03/27/2025
 
 
TXT FDA to Cut Another 3,500 Employees Under HHS Plan
03/27/2025
 
 
TXT FDA Likely to Miss Review Deadlines: Staff
03/27/2025
 
 
TXT Prometheus, Owner Paying $550,000 for False Claims
03/27/2025
 
 
TXT Merck Seeks Approval for Subcutaneous Keytruda
03/27/2025
 
 
TXT Fresenius Prolia, Xgeva Biosimilars Approved
03/27/2025
 
 
TXT Makary Wins Senate Floor Vote on FDA Confirmation
03/26/2025
 
 
TXT CGMP Violations at China’s Yangzhou Sion
03/26/2025
 
 
TXT AstraZeneca Touts New Tagrisso Data
03/26/2025
 
 
TXT Exer Labs Illegally Marketing Exer Scan: FDA
03/26/2025
 
 
TXT Essure Issues Web Page Updated
03/26/2025
 
 
TXT Maintain, Apply Tabloid Guidance: Petition
03/26/2025
 
 
TXT Lytgobi Web Page False, Misleading: FDA
03/26/2025
 
 
TXT Approvable Letter for Sleep Apnea Device
03/26/2025
 
 
TXT Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J
03/26/2025
 
 
TXT 7 QS Violations in Dexcom Inspection
03/25/2025
 
 
TXT API Deviations at Aspen Biopharma Labs
03/25/2025
 
 
TXT Smiths Medical Recalls Endotracheal Tubes
03/25/2025
 
 
TXT Cassava Says Simufilam Failed in Alzheimer’s Study
03/25/2025
 
 
TXT Confirmatory Evidence in Non-Oncologic Rare Diseases
03/25/2025
 
 
TXT Regulate Silver Fluoride as Drug: Petition
03/25/2025
 
 
TXT Solriamfetol Phase 3 Trial Meets Endpoints
03/25/2025
 
 
TXT Vaccine Studies Should Have Transmission Rate Data: Marks
03/25/2025
 
 
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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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