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FDA-RELATED NEWS
 
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TXT FDA Clears Olympus Endoscope Series
05/27/2025
 
 
TXT Savara Gets Refusal-to-File Letter for Molbreevi BLA
05/27/2025
 
 
TXT BD Recalls Esophagogastric Balloon Tamponade Tubes
05/23/2025
 
 
TXT FDA Approves Liquidia’s Pulmonary Hypertension Drug
05/23/2025
 
 
TXT Susvimo Approved for Diabetic Retinopathy
05/23/2025
 
 
TXT FDA Backs Covid JN.1-Lineage for Next Boosters
05/23/2025
 
 
TXT Judge Blocks Mass Federal Layoffs Pending Appeal
05/23/2025
 
 
TXT Centerline Bio Recalls Catheter Guidewire
05/22/2025
 
 
TXT MAHA Assessment Details ‘Children’s Health Crisis’
05/22/2025
 
 
TXT Makary Takes Heat for Budget, Mass Firings at Hearing
05/22/2025
 
 
TXT GAO Faults FDA Organ-on-a-Chip Regulation
05/22/2025
 
 
TXT Biocompatibility Testing Labs Falsified Data: FDA
05/22/2025
 
 
TXT ‘Serious’ Research Issues at United Health Products: FDA
05/22/2025
 
 
TXT Accelerated Approval Works: Friends of Cancer Research
05/22/2025
 
 
TXT Tariffs Could Hurt Drug Supply: HuffPost
05/22/2025
 
 
TXT Microspecialties Quality System Issues
05/21/2025
 
 
TXT Expand mRNA Covid Vaccine Warnings: FDA
05/21/2025
 
 
TXT Bipartisan Bill to Codify Trump Drug Price Order
05/21/2025
 
 
TXT Moderna Withdraws Pending BLA for Flu/Covid Vaccine
05/21/2025
 
 
TXT QS Violations in NeuroSync Inspection
05/21/2025
 
 
TXT Ethicon Endo-Surgery Recalls Surgical Stapler
05/21/2025
 
 
TXT FDA Warns Sarfez About Soaanz Promotional Materials
05/20/2025
 
 
TXT Covid Vaccine Policy on Boosters and New Trials
05/20/2025
 
 
TXT SSRI/SNRI Labeling Changes Sought
05/20/2025
 
 
TXT FDA Approves Bayer’s Jivi Antihemophilic Factor
05/20/2025
 
 
TXT Panel Wants More U.S. Patient Data on Glofitamab
05/20/2025
 
 
TXT 48 New, Revised PSGs Out
05/20/2025
 
 
TXT Miller Named Acting Inspections Chief
05/20/2025
 
 
TXT FDA Chief Counsel Post on Hold for Now
05/19/2025
 
 
TXT Formycon Wins Stelara Interchangeability for Biosimilar
05/19/2025
 
 
TXT Novavax Covid Vaccine Approved After Trial Agreement
05/19/2025
 
 
TXT Severe Itching Linked to Allergy Drugs
05/19/2025
 
 
TXT Stryker Nerve Ablator Cleared for Back Pain
05/19/2025
 
 
TXT PharmaTher Ketamine NDA Review Extended by FDA
05/16/2025
 
 
TXT Makary to Testify at 5/22 Budget Hearing
05/16/2025
 
 
TXT Scynexis Clinical Hold Lifted on Antifungal
05/16/2025
 
 
TXT Fujirebio Diagnostics Gets Alzheimer’s Test Cleared
05/16/2025
 
 
TXT FDA Raises Issues on 4 Cancer Drugs at Panel
05/16/2025
 
 
TXT Troriluzole PDUFA Action Date Extended
05/15/2025
 
 
TXT FDA Initiatives Help Early-Phase Cancer Trials: Post
05/15/2025
 
 
TXT Roche Companion Diagnostic for AbbVie’s Emrelis OK’d
05/15/2025
 
 
TXT Agency Has ‘Evolved’ in the Last 10 Years: Verdun
05/15/2025
 
 
TXT Makary Says Vaccine Framework Coming Soon
05/15/2025
 
 
TXT Amneal’s Brekiya Approved for Migraines
05/15/2025
 
 
TXT FDA Accepts BioCryst Orladeyo NDA
05/15/2025
 
 
TXT Positive Data on Keytruda in Ovarian Cancer: Merck
05/15/2025
 
 
TXT CGMP Violations at China’s Shantou S.E.Z. Baojie
05/14/2025
 
 
TXT FDA Doubts May Move Trials Overseas: Report
05/14/2025
 
 
TXT FDA OKs First Oral Therapy for Rare Adrenal Tumors
05/14/2025
 
 
TXT GAO Pushes Its FDA Recommendations to Kennedy
05/14/2025
 
 
TXT Malaysia’s BioAsia Worldwide CGMP Issues
05/14/2025
 
 
TXT Hunter Syndrome Gene Therapy Accepted for Review
05/14/2025
 
 
TXT Indian API Maker Hit with Warning Letter
05/13/2025
 
 
TXT FDA Wants Public Deregulation Input
05/13/2025
 
 
TXT CGMP Violations at Excelvision Fareva
05/13/2025
 
 
TXT FDA Moves to Ban Pediatric Ingestible Fluoride Drugs
05/13/2025
 
 
TXT Assertio Pays $3.6 Million Over Improper Marketing
05/13/2025
 
 
TXT Taizhou Jingshang Cosmetics CGMP Issues
05/13/2025
 
 
TXT FDA Hits Mayne Nextstellis Professional Presentation
05/13/2025
 
 
TXT GSK, iTeos Therapeutics Scrap Lung Cancer Candidate
05/13/2025
 
 
TXT FDA Needs GLP-1 Long-Range Plan: Kessler
05/13/2025
 
 
TXT Capillary Bio Wearable Infusion Set Cleared
05/13/2025
 
 
TXT FDA Pulled Into Drug Pricing Fray
05/12/2025
 
 
TXT United Imaging X-ray System Cleared
05/12/2025
 
 
TXT Chikungunya Vaccine on Pause Due to Safety Concerns
05/12/2025
 
 
TXT Beam Gets Regenerative Medicine Status for Gene Therapy
05/12/2025
 
 
TXT Thermosome Gets Orphan Status on Sarcoma Drug
05/12/2025
 
 
TXT Zepbound Beats Wegovy in Trial: Lilly
05/12/2025
 
 
TXT CBER Director Prasad on Striking the Right Data Balance
05/09/2025
 
 
TXT Parkinson’s Therapy Gets Regenerative Medicine Status
05/09/2025
 
 
TXT FDA Preparing for Drug User Fee Negotiations
05/09/2025
 
 
TXT Makary Says Novavax BLA Decision is Forthcoming
05/09/2025
 
 
TXT Teal Health At-Home Pap Smear Approved
05/09/2025
 
 
TXT FDA Misses GSK Nucala for COPD Review Decision
05/08/2025
 
 
TXT Odds Low for DTC Ad Ban: Conference Speakers
05/08/2025
 
 
TXT Gottlieb, McClellan Hit FDA Reorganization Plan
05/08/2025
 
 
TXT FDA Ombudsman Recommends Stakeholder Education
05/08/2025
 
 
TXT FDA Implementing AI-Assisted Scientific Review
05/08/2025
 
 
TXT Court Confirms FDA Drug Shortage Ruling was Valid
05/08/2025
 
 
TXT Michael Rogers Resigns from FDA
05/07/2025
 
 
TXT FDA Picks Booz Allen’s Walsh as AI Chief
05/07/2025
 
 
TXT Teva/Alvotech’s Interchangeable Stelara Biosimilar OK’d
05/07/2025
 
 
TXT Inspection Disruptions Won’t Rise to Covid Level: Expert
05/07/2025
 
 
TXT Theriva’s Pancreatic Cancer Drug Hits Endpoints
05/07/2025
 
 
TXT Moderna Flu/Covid Vaccine Beats Comparators: Study
05/07/2025
 
 
TXT Omeros BLA Resubmission for Narsoplimab
05/07/2025
 
 
TXT Bill Would Create FDA Inspector General
05/07/2025
 
 
TXT FDA Panel to Mull Covid Vaccine Strain Selection
05/07/2025
 
 
TXT More Unannounced Foreign Inspections Coming
05/06/2025
 
 
TXT FDA Ordered to Speed U.S. Drug Manufacturing
05/06/2025
 
 
TXT Vinay Prasad Tapped as New CBER Director
05/06/2025
 
 
TXT BIMO Inspection e-Submission Requirements Outlined
05/06/2025
 
 
TXT RM Pharma Gains Low-Dose HemiClor Approval
05/06/2025
 
 
TXT Clinical Trials for Covid Boosters: Makary
05/06/2025
 
 
TXT Teleflex Gains Expanded Use on QuikClot Device
05/06/2025
 
 
TXT Amicis Research Didn’t Follow Investigation Plan: FDA
05/06/2025
 
 
TXT Experts Dismiss FDA Drug Development Tools Program
05/05/2025
 
 
TXT Lab Test Ruling Could Apply to AI at FDA: Researchers
05/05/2025
 
 
TXT ImmunityBio sBLA Filing Refused on Expanded Indication
05/05/2025
 
 
TXT Capricor Therapeutics Passes Mid-Cycle Review
05/05/2025
 
 
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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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