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FDA-RELATED NEWS
 
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TXT FDA Full Approval for Lilly’s Retevmo
09/27/2024
 
 
TXT 3 FDA Clinical Trial Guidances Analyzed
09/26/2024
 
 
TXT Pfizer Pulls Oxbryta Sickle Cell Drug
09/26/2024
 
 
TXT Stakeholder Diversity Action Plan Comments
09/26/2024
 
 
TXT Hold Lifted on Biomea Fusion Diabetes Trials
09/26/2024
 
 
TXT Conflict of Interest Seen in Kisunla Approval
09/26/2024
 
 
TXT AbbVie Parkinson’s Trial Meets Endpoints
09/26/2024
 
 
TXT FDA Proposal to Reclassify HBV Assays
09/26/2024
 
 
TXT Info Collection on Device Recall Authority
09/25/2024
 
 
TXT Merck Favezelimab/Keytruda Trial Misses Endpoint
09/25/2024
 
 
TXT FDA Posts 2 FDA-483s
09/25/2024
 
 
TXT Democrat Lawmakers Seek Probe of Shuren Conflicts
09/25/2024
 
 
TXT FDA, CBP Seize Counterfeit Weight Loss Drugs
09/25/2024
 
 
TXT More Support for Treating All Biologics the Same
09/25/2024
 
 
TXT FDA OKs AZ’s Tagrisso Lung Cancer Drug
09/25/2024
 
 
TXT Lilly Sues FDA Over Retatrutide Designation
09/25/2024
 
 
TXT Azurity Selling Unapproved Drugs: FDA
09/24/2024
 
 
TXT ODAC Discussing Immune Checkpoint Inhibitors
09/24/2024
 
 
TXT Treat all Biologics the Same: Stakeholders
09/24/2024
 
 
TXT House Passes Pediatric/Rare Disease Bill
09/24/2024
 
 
TXT Eisai Facility FDA-483 Out
09/24/2024
 
 
TXT Arcutis Bio Files sNDA for Zoryve Expanded Use
09/24/2024
 
 
TXT 5 Observations on Hugel FDA-483
09/24/2024
 
 
TXT Braun Introcan Deep Access Catheter Cleared
09/24/2024
 
 
TXT Topside Change at CDRH Continues its Corruption
09/23/2024
 
 
TXT Korea’s C&T Dream Co. Gets Form-483
09/23/2024
 
 
TXT Gilead Recalls Veklury Over Glass Particle
09/23/2024
 
 
TXT FDA Taps Industry Vet as Device Evaluation Chief
09/23/2024
 
 
TXT Ideaya Bio Plans Phase 3 for Darovasertib
09/23/2024
 
 
TXT FDA OKs 3 New Indications for Bimzelx
09/23/2024
 
 
TXT Smiths Recalls ParaPAC Ventilators
09/20/2024
 
 
TXT Zevra’s Niemann-Pick Disease Drug Approved
09/20/2024
 
 
TXT CMC Development and Readiness Pilot
09/20/2024
 
 
TXT 3 FDA Guides on Device Accreditation Scheme for Conformity
09/20/2024
 
 
TXT Sanofi’s Sarclisa OK’d for Multiple Myeloma
09/20/2024
 
 
TXT FDA OKs Rybrevant for Expanded Indication
09/20/2024
 
 
TXT Medical Device Biocompatibility Guidance
09/19/2024
 
 
TXT RFK Jr. to Recommend Trump Health Agency Heads?
09/19/2024
 
 
TXT CDER Biosim. Interchangeability Change Explained
09/19/2024
 
 
TXT Elanco Gets Anti-Itch Zenrelia Approved for Dogs
09/19/2024
 
 
TXT FDA Hits Spanish Drug Facility with 483
09/19/2024
 
 
TXT Vanda Hits FDA for Rejecting Tradipitant
09/19/2024
 
 
TXT Panel to Discuss Seasonal and Avian Flu Preparedness
09/19/2024
 
 
TXT Contaminated Atovaquone Recalled by Bionpharma
09/19/2024
 
 
TXT Braun Medical Expands Infusion Pump Recall
09/18/2024
 
 
TXT FDA Posts FDA-483s from 2 Indian Companies
09/18/2024
 
 
TXT Firms Seek Broad Extrapolation for Pediatric IBD Dosing
09/18/2024
 
 
TXT Rubio, King Push FDA on Advanced Drug Manufacturing
09/18/2024
 
 
TXT ICER Questions Diversity Action Plan Goal
09/18/2024
 
 
TXT FDA OKs Keytruda Pleural Mesothelioma Indication
09/18/2024
 
 
TXT Bill Introduced on Generic Drug Prompt Approvals
09/18/2024
 
 
TXT FDA Review of Govorestat on Track: Company
09/18/2024
 
 
TXT Fasenra OK’d for Rare Vasculitis
09/18/2024
 
 
TXT Decentralized Clinical Trial Guidance
09/17/2024
 
 
TXT CGMP Violations at TJA Health
09/17/2024
 
 
TXT Quality CDMO Marketing Unapproved Drugs: FDA
09/17/2024
 
 
TXT Consider Phased DSCSA Enforcement: PhRMA
09/17/2024
 
 
TXT Kisqali Expanded Approval for Early Breast Cancer
09/17/2024
 
 
TXT FDA Lifts Partial Clinical Hold on Alzheimer’s Drug
09/17/2024
 
 
TXT Positive Data Reported on Lung Cancer Therapy
09/17/2024
 
 
TXT Integrating RCTs into Routine Clinical Practice
09/17/2024
 
 
TXT Safety Alert on Zimmer Hip System
09/17/2024
 
 
TXT FDA Extends Treosulfan NDA Review by 3 Months
09/16/2024
 
 
TXT SSM St. Clare Health Gets FDA-483
09/16/2024
 
 
TXT Guide on Oncology Multiregional Clinical Trials
09/16/2024
 
 
TXT Apple Watch Cleared for Assessing Sleep Apnea
09/16/2024
 
 
TXT Boehringer Ingelheim Plans Pulmonatry Fibrosis NDA
09/16/2024
 
 
TXT Fresenius Recalls Ivenix Pump Administration Sets
09/16/2024
 
 
TXT Clinical Hold Lifted on Zentalis’ Azenosertib
09/16/2024
 
 
TXT FDA Corrects ANDA Approval Withdrawals from 6/21
09/13/2024
 
 
TXT Expanded Approval for Dupixent in Rhinosinusitis
09/13/2024
 
 
TXT Lilly’s Ebglyss Approved for Eczema
09/13/2024
 
 
TXT FDA Clears SamanTree’s Histolog Scanner
09/13/2024
 
 
TXT Genentech’s Ocrevus Zunovo Approved for MS
09/13/2024
 
 
TXT Senators Introduce Bill to Reduce Animal Testing
09/13/2024
 
 
TXT Feedback Sought on Integrated Review Document
09/12/2024
 
 
TXT FDA Veozah Liver Injury Warning
09/12/2024
 
 
TXT Recommendations on Rare Disease Collaboration
09/12/2024
 
 
TXT FDA Publishes 8th Revision of Electronic Format Guide
09/12/2024
 
 
TXT Apple AirPods Hearing Software Authorized
09/12/2024
 
 
TXT Tremfya Secures Approval for Ulcerative Colitis
09/12/2024
 
 
TXT Gilead Positive on Twice-Yearly HIV Drug Data
09/12/2024
 
 
TXT GSK Moves mRNA Flu Vaccine to Phase 3
09/12/2024
 
 
TXT GDUFA ANDA Amendment Submissions
09/11/2024
 
 
TXT OPDP Hits AbbVie Over Serena Williams DTC Ad
09/11/2024
 
 
TXT 3 FDA Innovative Manufacturing Action Steps
09/11/2024
 
 
TXT FDA Warns 2 Chinese Labs About Data Concerns
09/11/2024
 
 
TXT Lawsuit Against FDA Dismissed on Ripeness Grounds
09/11/2024
 
 
TXT Ocaliva Confirmatory Trial Fails: FDA
09/11/2024
 
 
TXT CDER Quantitative Medicine CoE Explained
09/11/2024
 
 
TXT Follow FDA Online Misinformation Guidance: Attorneys
09/10/2024
 
 
TXT DeepWell Digital Software Cleared for Stress Relief
09/10/2024
 
 
TXT CGMP Violations at Zydus Lifesciences Facility
09/10/2024
 
 
TXT Multiple Optikem International Violations Cited
09/10/2024
 
 
TXT Changes Sought in FDA Misinformation Guidance
09/10/2024
 
 
TXT FDA Clears Sonic Incytes’ Velacur Device
09/10/2024
 
 
TXT FDA Mulls More Post-Inspection Feedback: Cavazzoni
09/10/2024
 
 
TXT CBER Updates Refusal-to-File Procedure
09/09/2024
 
 
TXT GSK Highlights Depemokimab Asthma Data
09/09/2024
 
 
TXT Hold Removed on Rezolute Hypoglycemia Drug
09/09/2024
 
 
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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;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
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