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FDA-RELATED NEWS
 
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TXT RSV Vaccines Get Guillain-Barré Warning
01/07/2025
 
 
TXT Ionis’ Spinraza Approved by FDA for SMA
01/06/2025
 
 
TXT Guide on Device Supply Interruption Notifications
01/06/2025
 
 
TXT Guide on Seeing if Confirmatory Study Underway
01/06/2025
 
 
TXT Inogen Airway Clearance Device Cleared
01/06/2025
 
 
TXT FDA OKs Galderma Dermatitis Drug Nemluvio
01/06/2025
 
 
TXT Alcon Recalls Systane Ultra PF Eye Drops
01/06/2025
 
 
TXT FDA OKs Array’s Braftovi for Some Cancers
01/06/2025
 
 
TXT Guide on Clinical Trials Using Tissue Biopsies
01/06/2025
 
 
TXT Draft Guide on Using AI for Drug Development
01/06/2025
 
 
TXT Neumora’s Phase 3 Depression Study Misses Endpoints
01/06/2025
 
 
TXT CDER Approved 50 Novel Products Last Year
01/06/2025
 
 
TXT FDA Alert on Boston Accolade Pacers Early Replacement
01/03/2025
 
 
TXT FDA Approves Xcovery’s Ensacove for Some Lung Cancers
01/03/2025
 
 
TXT FDA Approves Humacyte’s Symvess
01/03/2025
 
 
TXT QS, MDR Violations at Rontis Hellas in Greece
01/03/2025
 
 
TXT FDA Approves BMS’ Opdivo Qvantig Injection
01/03/2025
 
 
TXT FDA Approves Novo Hemophilia Prophylaxis Drug
01/03/2025
 
 
TXT New Sleep Apnea Indication for Lilly’s Zepbound
01/03/2025
 
 
TXT Astellas Recalls Lots of Prograf and Astagraf
01/03/2025
 
 
TXT Bhargava Phytolab CGMP Violations
01/03/2025
 
 
TXT FDA Wants Labeling Changes for Buprenorphine
01/03/2025
 
 
TXT Global Unique Device ID Database Guidance
01/03/2025
 
 
TXT FDA Approves Checkpoint’s Unloxcyt
01/03/2025
 
 
TXT Axsome Plans Alzheimer’s NDA on Mixed Data
01/03/2025
 
 
TXT Exclude Liraglutide from Compounding: Novo Nordisk
01/03/2025
 
 
TXT Mylan 6-Item Form FDA-483 Posted
01/03/2025
 
 
TXT Guide on Drug Batch Uniformity and Integrity
01/03/2025
 
 
TXT Chimerix NDA for Glioma Drug
01/03/2025
 
 
TXT CGMP Violations in Micro Orgo Chem Inspection
01/03/2025
 
 
TXT Temple Retires; Bumpus Leaves FDA
01/02/2025
 
 
TXT Xbrane Refiles Lucentis Biosimilar BLA
01/02/2025
 
 
TXT Alert on AquaFlexFlow Blood Circuits
01/02/2025
 
 
TXT Senators Introduce Skinny Label Generic Drug Bill
01/02/2025
 
 
TXT Sombra Cosmetics CGMP Violations
01/02/2025
 
 
TXT FDA OKs Mesoblast’s Ryoncil Cell Therapy
01/02/2025
 
 
TXT Clinical Investigation Protocol Deviations
01/02/2025
 
 
TXT Updated POLARx Instructions is Class 1 Recall: FDA
01/02/2025
 
 
TXT FDA Seeks Comments on ODAC Briefing Guidance
01/02/2025
 
 
TXT CGMP Violations in Akorn Formulations Review
01/02/2025
 
 
TXT ICH M15 Model-Informed Drug Development Principles
01/02/2025
 
 
TXT AMT Designation Program Guidance
01/02/2025
 
 
TXT ICH E11A Pediatric Extrapolation Guidance
01/02/2025
 
 
TXT ICH Clinical Practice Guide Annex
01/02/2025
 
 
TXT Multiple Violations in BD Inspection
01/02/2025
 
 
TXT Brands International Limits, Delays Inspection: FDA
01/02/2025
 
 
TXT CRL for Zealand’s SBS Treatment NDA
01/02/2025
 
 
TXT Quality, Data Issues at Mylan Facility in India
01/02/2025
 
 
TXT Boxed Warning for Veozah Liver Injury
01/02/2025
 
 
TXT Lexicon Dropping Zynquista After CRL
01/02/2025
 
 
TXT Hologic BioZorb Marker Recall Class 1: FDA
01/02/2025
 
 
TXT UCB Minzasolmin Parkinson’s Study Misses Endpoints
01/02/2025
 
 
TXT FDA Alert on Baxter Solution Sets
01/02/2025
 
 
TXT NEWSROOM CLOSED FOR THE HOLIDAYS
12/14/2024
 
 
TXT Zimmer Biomet Stemless Shoulder System
12/13/2024
 
 
TXT CDER Right-to-Try Summaries Can Go Thru Portal
12/13/2024
 
 
TXT Guide on Tech Specs for NASH Drug Data Sets
12/13/2024
 
 
TXT FDA Promotes Centralized Statistical Trial Monitoring
12/13/2024
 
 
TXT McKinsey & Co. Pays $650 Million in Opioid Case
court
12/13/2024
 
 
TXT FDA Sees New Ocaliva Liver Injuries
12/12/2024
 
 
TXT FDA Hasn’t Inspected Factory with Recalls: ProPublica
12/12/2024
 
 
TXT Trump Unclear on Abortion Pills in Interview
12/12/2024
 
 
TXT Generics Seek Legislation to End Drug Sameness Delays
12/12/2024
 
 
TXT U.S. Approves More New Drugs than EU, Japan: Analysis
12/12/2024
 
 
TXT J&J Impella Heart Pumps Get Expanded Indications
12/12/2024
 
 
TXT DTC Ad Enforcement to Increase Under Trump: Panel
12/12/2024
 
 
TXT Regulating AI in Healthcare: Paragon White Paper
12/11/2024
 
 
TXT Fresenius Kabi Pump Early Alert
12/11/2024
 
 
TXT Stakeholders Comment on Patient Preference Guide
12/11/2024
 
 
TXT Furosemide Injection sNDA Faces Submission Delay
12/11/2024
 
 
TXT CDER Wants AI Use in Drug Safety: Attorneys
12/11/2024
 
 
TXT Advisory Panel to Discuss Pediatric RSV Vaccine Safety
12/11/2024
 
 
TXT NIH Ends Mpox Study Early
12/11/2024
 
 
TXT Carvykti Shows Favorable Minimal Residual Disease Data
12/10/2024
 
 
TXT OCI Case Nets 2 on HIV, Covid Drug Convictions
12/10/2024
 
 
TXT CGMP Violations at China’s Guangzhou Four E’s
12/10/2024
 
 
TXT Getinge/Maquet Recalls VasoView HemoPro 2
12/10/2024
 
 
TXT FDA Stem Cell Regulation Court Ruling Analyzed
12/10/2024
 
 
TXT FDA Denies Metacel Ozobax Petition
12/10/2024
 
 
TXT ICH Model-Informed Drug Development Guide Out
12/10/2024
 
 
TXT Favorable Pirtobrutinib Data in Leukemia/Lymphoma: Lilly
12/10/2024
 
 
TXT Update on Baxter Recall of Hemodialysis Transfer Sets
12/09/2024
 
 
TXT GSK Files for Nucala COPD Indication
12/09/2024
 
 
TXT Mixed Results on Keytruda Ovarian Cancer Study
12/09/2024
 
 
TXT FDA Clears Prostate Tissue Ablator
12/09/2024
 
 
TXT AbbVie Reports Positive Parkinson’s Trial Data
12/09/2024
 
 
TXT Chimerix Plans Accelerated Approval NDA for Gliomas Drug
12/09/2024
 
 
TXT Fresenius Hit With 11-Item FDA-483
12/09/2024
 
 
TXT e-Submission Guide for BIMO Inspection Planning
12/06/2024
 
 
TXT Panel to Discuss Opioid Abuse Studies
12/06/2024
 
 
TXT Drug/Biologic Accelerated Approval Draft Guide
12/06/2024
 
 
TXT GE Healthcare Recalls Newborn Incubators
12/06/2024
 
 
TXT Groups Urge Rare Disease Voucher Reauthorization
12/06/2024
 
 
TXT FDA Loses Again in FOIA Suit on Vaccine Records
12/06/2024
 
 
TXT FDA Finds Lab Issues at Musk Plant
12/05/2024
 
 
TXT Updated Accelerated Approval Guidance
12/05/2024
 
 
TXT FDA Approves AZ’s Lung Cancer Drug Imfinzi
12/05/2024
 
 
TXT Rayner Wants Generic Omidria Restrictions
12/05/2024
 
 
TXT Protara Reports Positive Data on Bladder Cancer Drug
12/05/2024
 
 
TXT EpicentRx Gets Fast Track for Sarcoma Therapy
12/05/2024
 
 
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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:
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