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Boxed Warning for Veozah Liver Injury 01/02/2025

Lexicon Dropping Zynquista After CRL 01/02/2025

NEWSROOM CLOSED FOR THE HOLIDAYS 12/14/2024

Zimmer Biomet Stemless Shoulder System 12/13/2024

CDER Right-to-Try Summaries Can Go Thru Portal 12/13/2024

Guide on Tech Specs for NASH Drug Data Sets 12/13/2024

FDA Promotes Centralized Statistical Trial Monitoring 12/13/2024

McKinsey & Co. Pays $650 Million in Opioid Case court 12/13/2024

Syndax Leukemia Review Extended by FDA 07/29/2024

NEWSROOM CLOSED FOR THE HOLIDAYS 12/18/2023

FDA OKs Merck Kidney Cancer Drug 12/17/2023

FDA OKs Glaukos Intraocular Pressure Drug Implant 12/17/2023

2 Imbruvica Accelerated Approvals Withdrawn 12/17/2023

DTC Survey Examines Quantitative Claims 12/17/2023

FDA Updates Breast Implant Safety Info 12/17/2023

Guide on Priority Zoonotic Animal Drugs 12/17/2023

Moderna Inspection Cites GMP Issues: Report 12/17/2023

FDA Warns Makers of Illegal Animal Antimicrobials 12/14/2023

FDA in 3 More Collaborative Communities 12/14/2023

House Committee Threatens FDA Subpoena 12/14/2023

FDA ‘Doing Little’ on Social Media Drug Claims: Report 12/14/2023

Pharmasol Permanent Injunction Approved 12/14/2023

Clinical Hold on 3 CARsgen CAR T-cell Therapies 12/14/2023

Stakeholder Technical Issues with Ophthalmic Guide 12/14/2023

FDA Approves Neuroblastoma Drug 12/14/2023

Update GAO Device Recall Oversight Report: Senators 12/13/2023

Novid Distributing Unapproved, Misbranded Drug: FDA 12/13/2023

Guide on Advanced Manufacturing Tech 12/13/2023

Regulatory Affairs, Foods Program Under Review 12/13/2023

HELP Committee OKs EFFECTIVE Opioid Bill 12/13/2023

GOP Senators Urge Increase in Foreign Inspections 12/13/2023

Amgen Files Priority BLA for Lung Cancer 12/13/2023

AdvaMed Faults FDA on ‘Safety’ 510(k) Guidances 12/13/2023

Supreme Court Agrees to Hear Mifepristone Case 12/13/2023

FDA OK’s Ferring’s Bladder Cancer Gene Therapy 12/16/2022

Panel to Examine Ongoing Covid Vaccine Modifications 12/16/2022

Contractor Conflict-of Interest Bill Passes Congress 12/16/2022

Aurigene Ditches Psoriasis Drug Candidate 12/16/2022

Providence Medical Tech Cavux Facet Device Cleared 12/16/2022

Draft Guide on Pulmonary Tuberculosis Drugs 12/15/2022

Draft Inspection Refusal Guidance 12/15/2022

FDA Stem Cell Therapy Regulation at Risk: Attorneys 12/15/2022

FDA Updates CRL Guidance Performance Goals 12/15/2022

Comments on Immune-Mediated Adverse Reaction Guidance 12/15/2022

Independent FDA Needed to Stop Political Meddling: GAO 12/15/2022

States Pushing for Canadian Drug Imports: Report 12/14/2022

Harmonize Innovative Manufacturing Regulation: PhRMA 12/14/2022

AdvaMed Supports Breakthrough Device Guidance Updates 12/14/2022

VALID Could Hurt Home Sample Testing: Attorneys 12/14/2022

Former NECC Ops Director Sentenced to 5 Months in Jail 12/14/2022

FDA Panel Thumbs Down on Heart Failure Drug 12/14/2022

FDA Accepts NDA for Eye Dilating Combo Product 12/13/2022

$2.25 mil. RWD Funding Opportunity 12/13/2022

CGMP Deviations Seen in Centrient Inspection 12/13/2022

Clinicians Need Refresher on Clinical Trial Statistics: Survey 12/13/2022

What’s Behind the New LASIK Guidance? 12/13/2022

Assign TE Codes for All Approved Drugs: Study 12/13/2022

Change Antibiotic Development Incentives: Study 12/13/2022

Moderna/Merck Cancer Vaccine Meets Endpoint 12/13/2022

Doc Group Wants FDA Probe of Musk’s Neuralink 12/13/2022

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