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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

Senator Calls on FDA to Probe Respironics 10/11/2023

Former FDAer Beitz Joins Law Firm 10/11/2023

FDA Needs to Define ‘Substantial Equivalence’ 10/11/2023

Ozempic Kidney Study Stopped Due to Efficacy Data 10/11/2023

No Care Access Issues in VALOR Trial: Company 10/11/2023

Cytoxan Not Withdrawn Over Safety/Efficacy 10/11/2023

Multiple Violations in Abiomed Inspection 10/10/2023

2 Unapproved GLP-1 Drug Marketers Warned: FDA 10/10/2023

Suggested Changes to ‘Underrepresented’ Draft Guide 10/10/2023

‘Minor Updates’ to 2 Magnetic Resonance Guidances 10/10/2023

Researcher Cited for ‘Objectionable Conditions’ 10/10/2023

FDA Cautions About Compounded Ketamine 10/10/2023

FDA QTc Draft Guidance ‘Too Vague’: NCHR 10/10/2023

CDRH Plans 24 Guidances in FY 2024 10/10/2023

FDA Diversity Plan Draft Guidance Due: RAPS 10/10/2023

Positive Keytruda Data in Lung Cancer: Merck 10/10/2023

Companion Diagnostic for Retevmo Approved 10/09/2023

Alnylam Gets ‘Complete Response’ on sNDA 10/09/2023

Biocon Gets Insulin Aspart BLA Rejection 10/09/2023

‘Breakthrough’ Status for Knee Implant 10/09/2023

11 Dr. Reddy’s ANDAs Withdrawn 10/09/2023

HistoSonics De Novo for Tumor Blaster 10/09/2023

AstraZeneca Seeks More Input on Study Diversity 10/09/2023

Sun Pharma NDA for Alopecia Areata 10/06/2023

2 Covid-19 Product EUAs Revoked 10/06/2023

Senator Urges Justice Probe of Respironics 10/06/2023

FDA OKs Zoryve Cream Expanded Use 10/06/2023

Syndax Reports ‘Positive’ Leukemia Data 10/06/2023

FDA’s Daunting Task to Tackle Misinformation: Califf 10/06/2023

FDA Clears Home Hemoglobin Test 10/06/2023

Clinical Hold for Innate Lacutamab Trials 10/05/2023

CDRH Marks 10 Years of Cybersecurity Program 10/05/2023

Reps Reiterate Call for VALID Act Passage 10/05/2023

FDA Looking Into Counterfeit Ozempic: Report 10/05/2023

Coherus Refiles Udenyca Onbody BLA Supplement 10/05/2023

AstraZeneca Comments on FDA QTc Draft Guidance 10/05/2023

Reagan-Udall Strategies to Understand Regulated Products 10/05/2023

FDA ‘Unsatisfied’ with Philips Respironics Recall 10/05/2023

Stimulant Use Disorder Treatment Guidance 10/04/2023

Medtronic Warns on Stolen Laryngoscopes 10/04/2023

No Safety Issues in Biosimilar Switches: Study 10/04/2023

‘Objectionable Conditions’ at Florida Doctor Site 10/04/2023

Attorney Blasts CDRH for 8,000-day Petition Delays 10/04/2023

User Fee Courier Delivery Address Change 10/04/2023

Moderna Phase 3 Trial for Flu/Covid Vaccine 10/04/2023

Signature Biologics Illegally Marketing Cord Product 10/03/2023

Repeat CGMP Deviations at Fresenius Unit 10/03/2023

Oncology Panel to Discuss Accelerated Approvals 10/03/2023

More Unannounced Inspections in India: Califf 10/03/2023

FDA Reviewers Question Amgen’s Lumakras Study 10/03/2023

AdvaMedDx Challenges Oncology Test Pilot 10/03/2023

FDA Allows Reformulated Novavax Vaccine 10/03/2023

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