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FDA-RELATED NEWS
 
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TXT Provepharm Recalls Phenylephrine HCl
01/27/2025
 
 
TXT Once Monthly Leqembi for Alzheimer’s Approved
01/27/2025
 
 
TXT Pfizer Pays $60 million to Settle Biohaven Kickbacks
01/27/2025
 
 
TXT Vanda Files NDA for Motion Sickness Drug
01/27/2025
 
 
TXT Stroke Device Cleared for Larger Catheters
01/27/2025
 
 
TXT Fast Track for Prostate Cancer Imaging Drug
01/24/2025
 
 
TXT ALX Oncology Seeking Accelerated OK for Evorpacept
01/24/2025
 
 
TXT FDA Approves Medexus Leukemia NDA
01/24/2025
 
 
TXT FDA Delays Non-Rx Drug Final Rule
01/24/2025
 
 
TXT CDRH’s Sara Brenner Elevated to Acting Commissioner
01/24/2025
 
 
TXT Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer
01/24/2025
 
 
TXT FDA Will Review Biogen Spinraza sNDA
01/23/2025
 
 
TXT FDA Removes ‘Diversity’ Docs From Web Site
01/23/2025
 
 
TXT Former FDA Women’s Health Head Wood Dies
01/23/2025
 
 
TXT FDA Extends Review of Stealth Bio NDA
01/23/2025
 
 
TXT Continue Strong Compliance, Quality Programs: Attorneys
01/23/2025
 
 
TXT Implement Digital Technologies Carefully: GE HealthCare
01/23/2025
 
 
TXT Durbin, Grassley Reintroduce Drug Ad Price Bill
01/23/2025
 
 
TXT New Copaxone Boxed Warning
01/22/2025
 
 
TXT CBER Approved 67 Products in 2024: Report
01/22/2025
 
 
TXT FDA Wins Vanda Trade Secret Case
01/22/2025
 
 
TXT FDA Union Sues Trump Over Schedule F
01/22/2025
 
 
TXT Temporary Embargo on FDA Communications
01/22/2025
 
 
TXT FDA Lifts Hold on Cialis Rx-to-OTC Study
01/22/2025
 
 
TXT Woodcock Joins Friends of Cancer Research Board
01/22/2025
 
 
TXT Atara, FDA Agree on Steps to Lift Clinical Holds
01/21/2025
 
 
TXT Multiple Incell Violations Cited
01/21/2025
 
 
TXT Amended Sanofi Warning Letter
01/21/2025
 
 
TXT J&J Wins Monotherapy Use for Spravato
01/21/2025
 
 
TXT Biomarker Bioanalytical Method Validation
01/21/2025
 
 
TXT 7 Observations on SCA Pharmaceuticals FDA-483
01/21/2025
 
 
TXT FDA, Other Agencies Ordered Back in Office
01/21/2025
 
 
TXT Replimune BLA for Melanoma Gets Priority Review
01/21/2025
 
 
TXT Amylyx Clinical Hold Lifted on ALS Drug
01/21/2025
 
 
TXT FDA Lifts Alert on Neonatal Incubators
01/17/2025
 
 
TXT AstraZeneca’s Calquence Wins Traditional Approval
01/17/2025
 
 
TXT CDRH Authorized 120 Novel Devices in 2024
01/17/2025
 
 
TXT Animal Drug Regs Amended for Recent Approvals
01/17/2025
 
 
TXT Amgen’s Lumakras/Vectibix OK’d in Colon Cancer
01/17/2025
 
 
TXT CDER Commits to 11 Drug Quality Guides in 2025
01/17/2025
 
 
TXT FDA ‘Complete Response’ on Atara’s Ebvallo
01/16/2025
 
 
TXT Anti-Neuropathy Guidance for Cancer Drugs
01/16/2025
 
 
TXT FDA Seeks Comments on Cannabis Use in Animals
01/16/2025
 
 
TXT Commissioners’ Suggestions for Martin Makary
01/16/2025
 
 
TXT Boehringer Schizophrenia Cognition Trial Misses Endpoints
01/16/2025
 
 
TXT Medline Fluid Delivery Sets Recalled
01/16/2025
 
 
TXT FDA Early Alert on Fresenius Pump Software Updates
01/16/2025
 
 
TXT QS Violations at Xoran Technologies
01/15/2025
 
 
TXT 8 Observations in Phillips Precision Inspection
01/15/2025
 
 
TXT AdvaMed Trial Participation Snapshot Comments
01/15/2025
 
 
TXT Former McKinsey Exec Pleads Guilty in Opioid Case
01/15/2025
 
 
TXT Lilly’s Omvoh Wins Expanded Approval
01/15/2025
 
 
TXT FDA Policy Head Lands at King & Spalding
01/15/2025
 
 
TXT J&J Bladder Cancer Drug Under Review
01/15/2025
 
 
TXT Getinge/Maquet Recalls VasoView HemoPro 2 Devices
01/15/2025
 
 
TXT Vanda Can Seek Tradipitant Hearing: FDA Notice
01/15/2025
 
 
TXT 7 QS Issues at 3 Integra Facilities
01/14/2025
 
 
TXT Hologic QS and MDR Violations
01/14/2025
 
 
TXT 12 No-Longer-Marketed NDAs Withdrawn
01/14/2025
 
 
TXT OIG Faults 3 of 24 FDA Accelerated Approvals
01/14/2025
 
 
TXT Nitrosamine CPCA Expedites Drug Approvals: FDA
01/14/2025
 
 
TXT ANDA Oligonucleotide Guides Needed: AAM
01/14/2025
 
 
TXT Subcutaneous Leqembi BLA Accepted for Review
01/14/2025
 
 
TXT Icotec Carbon Fiber Spinal Infection Implant Cleared
01/14/2025
 
 
TXT Spear Bio Gets Breakthrough Status on Alzheimer's Test
01/14/2025
 
 
TXT Califf Final Essay Touts Covid Vaccines
01/13/2025
 
 
TXT Priority Review for Lung Cancer BLA
01/13/2025
 
 
TXT Philips Recalls ECG Mobile Monitoring App
01/13/2025
 
 
TXT Guide on Device PMA/HDE Modular Reviews
01/13/2025
 
 
TXT Rigel Pharma Gets Orphan Status for R289
01/13/2025
 
 
TXT FDA Turmoil Before Trump: CDER Chief Quits
01/10/2025
 
 
TXT 18,000 ‘Appalled’ Physicians Urge Senate Rejection of RFK Jr.
01/10/2025
 
 
TXT FDA Accepts NDA for Menkes Disease Drug
01/10/2025
 
 
TXT Tenpoint Therapeutics’ Positive Data on Vision Drug
01/10/2025
 
 
TXT CapsoVision Capsule Endoscopy Home Use Cleared
01/10/2025
 
 
TXT Vertex Cystic Fibrosis NDA Used Priority Voucher
01/09/2025
 
 
TXT FDA to Review Agios Pyrukynd sNDA
01/09/2025
 
 
TXT FDA Puts Marengo’s Invikafusp on Fast Track
01/09/2025
 
 
TXT Fresenius Recalls Ivenix Infusion Pumps
01/09/2025
 
 
TXT J&J Pauses Varipulse Rollout
01/09/2025
 
 
TXT Breakthrough Status for Heart Failure Device
01/09/2025
 
 
TXT Create Labeling-only NDA: Report
01/09/2025
 
 
TXT 6 Human Cell, Tissue Donor Eligibility Guides
01/08/2025
 
 
TXT Priority Review for Verastem Ovarian Cancer NDA
01/08/2025
 
 
TXT Diversity Action Plan Submissions Up
01/08/2025
 
 
TXT XO Biologix Marketing Unapproved, Adulterated Drug
01/08/2025
 
 
TXT FDA Fast Track for J&J Alzheimer’s Drug
01/08/2025
 
 
TXT 1st Cycle NDA Approvals Fall in 2024: CDER
01/08/2025
 
 
TXT FDA Sees ‘Challenges’ in Condoliase BLA
01/08/2025
 
 
TXT Vanda Criticizes FDA Over Drug Rejection
01/08/2025
 
 
TXT Anne’s Daye Pulls CBD Tampons in U.S.
01/08/2025
 
 
TXT Optical Imaging Drug Development Guidance
01/07/2025
 
 
TXT 5 Repeat CGMP Violations at Indoco Remedies
01/07/2025
 
 
TXT FDA Obesity/Overweight Drug Development Guide
01/07/2025
 
 
TXT ‘Off-Label’ Communications Q&A Guide
01/07/2025
 
 
TXT Rybrevant/Lazcluze Cancer Study Positive: J&J
01/07/2025
 
 
TXT 2 ALS Drugs Miss Endpoints
01/07/2025
 
 
TXT Lifecycle Recommendations for AI-Enabled Devices
01/07/2025
 
 
TXT Sex Differences in Clinical Evaluations of Products
01/07/2025
 
 
TXT RSV Vaccines Get Guillain-Barré Warning
01/07/2025
 
 
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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:
  • 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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