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Tonix Shuts Down Depression Drug Development 11/01/2023

New FDA Off-Label Guide Has ‘Challenges’: Lawyers 11/01/2023

FDA Sends 8-item 483 to NATCO Pharma 11/01/2023

Multiple Violations at WAVi Co. 10/31/2023

Stakeholders’ Views on FRAME 10/31/2023

Clinical Hold Lifted on Mersana’s XMT-2056 10/31/2023

Changes Sought to FDA’s IT Strategy 10/31/2023

API CGMP Deviations at Ali Pharmaceutical 10/31/2023

‘Objectionable Conditions’ at BTS Research 10/31/2023

FDA OKs Gene Therapy Trial for Heart Disease 10/31/2023

AdvaMed Points ONCD to Cyber Harmonization 10/31/2023

Amgen’s Interchangeable Stelara Biosimilar Approved 10/31/2023

FDA Should Develop Vision PRO Tool: AdvaMed 10/30/2023

FDA Warns on 26 Eye Drop Products 10/30/2023

Sarepta Seeking Gene Therapy Expanded Use 10/30/2023

GSK Jemperli Trial Meets Endpoint 10/30/2023

Novartis Seeks Accelerated OK for IgAN Drug 10/30/2023

Lilly’s Ulcerative Colitis Therapy Approved 10/27/2023

TX Man Gets 5 Years Over Unapproved Drugs 10/27/2023

Sickle Cell Therapy Safety Assessment Questioned 10/27/2023

Bill to Reduce Dependence on China Drugs 10/27/2023

Paige AI Lymph Node Gets Breakthrough 10/27/2023

FDA Trims, Updates Biosimilars Labeling 10/26/2023

Probiotics Can Hurt Hospitalized Preterm Infants: FDA 10/26/2023

Positive Data on Pfizer/BioNTech Combo Vaccine 10/26/2023

Olympus Recalls Insufflation Units 10/26/2023

Breakthrough Device Changes Needed: Research 10/26/2023

Qiagen, Myriad Partner on Cancer Diagnostics 10/26/2023

Add Device Identifier to Medicare Forms: Senators 10/26/2023

CDER Made ‘Erroneous Statements’ to A/C: Letter 10/25/2023

Remote Interactive Evaluation Guidance 10/25/2023

Medinol Gets OK on Latest Drug-Eluting Stent 10/25/2023

FDA Decision on Florida Drug Imports Delayed: Report 10/25/2023

Akebia Refiles Kidney Disease NDA 10/25/2023

‘Positive Results’ from BioXcel Data Audit 10/25/2023

Califf Positive on Visit to India 10/25/2023

Dermatologic Corticosteroid BE Guidance 10/25/2023

FDA Approves New Tibsovo Indication 10/24/2023

UCB Farchim FDA-483 Released 10/24/2023

FDA Changes Off-Label Approach: Attorney 10/24/2023

ResMed Recalls Astral 100, 150 Ventilators 10/24/2023

FDA Accepts sBLA for Self-Administered FluMist 10/24/2023

Predetermined Change Control Plan Principles 10/24/2023

Embryll Marketing Unapproved Animal Drug: FDA 10/24/2023

FDA Clears NKGen IND for Alzheimer’s Cell Therapy 10/24/2023

Genentech’s Rozlytrek Gets Expanded Use 10/24/2023

Guide on Scientific Info on Unapproved Uses 10/23/2023

FDA Approves Zymfentra as Maintenance Therapy 10/23/2023

Panacea Biotec Gets 9-item FDA-483 10/23/2023

Complete Response on Dupixent sBLA 10/23/2023

Medtronic Warning on McGrath Video Laryngoscopes 10/23/2023

Keytruda ‘Positive’ Data in Cervical Cancer 10/20/2023

Pfizer Pentavalent Meningococcal Vaccine Approved 10/20/2023

Philips Respironics Recalls V60 Ventilators 10/20/2023

Arrest Made in Misbranded Device Case 10/20/2023

BioMarin Expanded Indication for Voxzogo 10/20/2023

OCE Scientific Collaborative Research Areas 10/19/2023

Final Guide on Remote Monitoring Devices 10/19/2023

Hygienic Labs Didn’t Respond to FDA Data Requests 10/19/2023

BMS Seeking Approval of Subcutaneous Opdivo 10/19/2023

Confusion Exists in RWD/RWE Definitions: Analysis 10/19/2023

Regenerative Medicine Consensus Standards Guide 10/19/2023

FDA Updates AI/ML-Enabled Medical Device List 10/19/2023

Untitled Letter for India’s Nectar Lifesciences 10/19/2023

Guide on Drug, Biologic Benefit/Risk Assessment 10/18/2023

SeaStar Breakthrough Status for Cytopheretic Device 10/18/2023

Courts Could Cut FDA Labeling Enforcement: Avorn 10/18/2023

FCA Cases Look at Cybersecurity: Attorneys 10/18/2023

BrainStorm Pulls NurOwn BLA 10/18/2023

Non-Invasive Monitoring Enforcement Guide 10/18/2023

FDA Clears Intellia IND for Phase 3 Trial 10/18/2023

Praxis 510(k) for Biopsy Device Cleared 10/17/2023

Keytruda OK’d Before/After Lung Cancer Surgery 10/17/2023

‘Is Chevron Deference Dead?’: Ex-FDAer Pitts 10/17/2023

Guilty Plea in SphenoCath Case 10/17/2023

FDA Wants Comments on Innovative Clinical Trials 10/17/2023

Verrica Asks FDA to End Ycanth Compounding 10/17/2023

6 Observations in Samsung Biologics FDA-483 10/17/2023

FDA Denies UCB Generic Fintepla Petition 10/17/2023

Omeros Discontinues Narsoplimab Development 10/16/2023

Skyrizi Better Than Stelara: AbbVie Data 10/16/2023

Guide on Testing Pharmaceutical Alcohols 10/16/2023

Guidance on Diabetic Foot Infection Drugs 10/16/2023

Aldeyra Tussles With FDA on NDA Data 10/16/2023

GE HealthCare Update on Neonatal Incubators 10/16/2023

Priority Review for Tagrisso sNDA in Lung Cancer 10/16/2023

Device Inspection Compliance Program Revised 10/13/2023

Hogan Lovells Skeptical of New Generics Pilot 10/13/2023

FDA OKs Pfizer Ulcerative Colitis Drug 10/13/2023

InfoBionic Next-Gen Cardiac Monitor 10/13/2023

FDA to Study Adherence Effect on Promotion 10/12/2023

Topical Ophthalmic Drug Quality Guidance 10/12/2023

Stelara Biosimilar Gets ‘Complete Response’ 10/12/2023

Info Collection on Regulatory Misconduct Allegations 10/12/2023

3 Stakeholder Comments on FDA QTc Guidance 10/12/2023

14 House Dems Want ADHD Drug Shortage Info 10/12/2023

Fast Track for Glioblastoma Vaccine 10/12/2023

FDA Sets Digital Health Technologies A/C 10/11/2023

Cell, Gene Therapy Success Rates Analyzed 10/11/2023

Breakthrough Devices Could Aid Disadvantaged: Attorneys 10/11/2023

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