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Priority Review for BMS Lung Cancer Drug 05/30/2023

Concerns with Macular Degeneration Guidance 05/30/2023

Janssen NDA for Pulmonary Hypertension Drug 05/30/2023

Think Surgical Gains Clearance for TMINI Robot 05/30/2023

Pfizer’s Marstacimab Meets Phase 3 Goals 05/30/2023

Akebia Therapeutics Resubmitting Anemia NDA 05/30/2023

Suggestions for Oncology Accelerated Approval Guidance 05/30/2023

iRhythm Gets Warning Letter on Heart Monitor 05/30/2023

BMS Breyanzi ‘Deep and Durable Efficacy’ 05/26/2023

Progression-Free Survival Improves in DUO-E Trial: AZ 05/26/2023

3 Observations in UCB Pharma FDA-483 05/26/2023

Updated Boxed Warning for Rx Stimulants 05/26/2023

Comments on Gene, Cell Therapy Surveillance 05/26/2023

Colorectal Cancer NDA Gets Priority Review 05/26/2023

Neuralink Says FDA OKs Brain Implant Trial 05/26/2023

Sitravatinib Fails in Phase 3 Lung Cancer Study 05/25/2023

Power Morcellation Tissue Containment Guidance 05/25/2023

Trial Covariate Adjustment Guidance 05/25/2023

Drug, Medical Device Recalls Up in 1st Quarter 05/25/2023

Act on Cancer Chemo Shortages: Michigan Reps 05/25/2023

Pfizer Paxlovid NDA Approved for Covid 05/25/2023

Regenerelle Marketing Unapproved HCT/P Products: FDA 05/25/2023

Integra Recalls Products Over Endotoxin Testing 05/25/2023

Phathom Resubmits Vonoprazan NDA 05/24/2023

Generally Accepted Scientific Knowledge Guidance 05/24/2023

FDA Extends Review of Sarepta Gene Therapy 05/24/2023

Tox Study Whole Slide Imaging Guidance 05/24/2023

FDA Wants Comments on REMS Vendor Changes 05/24/2023

ICH Good Clinical Practice Guide Comments 05/24/2023

FDA Seeks Contractors for Drug Performance Automation 05/24/2023

FDA Warns India Pharmacy Over Unapproved Drugs 05/24/2023

SD Biosensor Recalls Contaminated Covid Tests 05/24/2023

Call Out Lawyer Client-Seeking Ads: Petition 05/24/2023

Ex-FDAer Schiller on Accelerated Approval Guide 05/23/2023

Melanoma Imaging Device Get Breakthrough Status 05/23/2023

Lawyer’s Motion to Remain Anonymous Granted 05/23/2023

FDA OK’s New Opioid Use Disorder Option 05/23/2023

Abbott Touts Data on Dual Chamber Pacemaker 05/23/2023

FDA Approval Reciprocity Bill Reintroduced 05/23/2023

FDA Denies Petition for PPI Pneumonia Warning 05/23/2023

Contract Testing Lab Gets Warning Letter 05/23/2023

New FDA MOU for Distributed Manufacturing 05/23/2023

Figures in Tellus Clinical Trial Fraud Case Acquitted 05/23/2023

Petition for Warning on Diabetes Drugs Denied 05/22/2023

CDRH Portal Expanded to Pre-Submission Feedback 05/22/2023

Novo Nordisk Plans NDA for Oral Obesity Drug 05/22/2023

Rain Oncology Scraps Milademetan 05/22/2023

FDA OKs Opiant Pharma’s Opioid Overdose Spray 05/22/2023

FDA Issues 483 to Aurobindo API Facility 05/19/2023

DTC Research Supports Disclosures on Endpoint Differentiation 05/19/2023

Abiomed Recalls Impella 5.5. Blood Pump 05/19/2023

Zoll Settles Case Against China-made ECG Cables 05/19/2023

Topical Gene Therapy for Wounds Approved 05/19/2023

‘Bionic Pancreas’ Cleared by FDA 05/19/2023

Revoke Approval for MSN’s Generic Hetlioz: Vanda 05/18/2023

Nephron Pharmaceuticals Warehouse FDA-483 05/18/2023

AbbVie Gets Rinvoq OK for Crohn’s 05/18/2023

Draeger Recalls Seattle CPAP Device and Components 05/18/2023

Child Cancer Research Bill Reintroduced 05/18/2023

House Dems Working on Cancer Drug Shortage 05/18/2023

Appropriators Cut FDA Budget by $600 million 05/18/2023

Panel Backs Pfizer’s RSV Vaccine 05/18/2023

2 Pediatric Drug Approval Guidances 05/17/2023

ICU Medical Recalls Pumps Over Battery Defect 05/17/2023

Device Panel to Tackle Health Equity 05/17/2023

Reviewers Question Intercept’s Liver Drug 05/17/2023

Bill to Use Industry Penalties for Cancer Research 05/17/2023

Califf Hopeful on Alzheimer’s, Obesity Drug Data 05/17/2023

Drug Company Patent Violations Cost $40 Billion: Study 05/17/2023

Reject Apotex Generic Fintepla ANDA: UCB 05/17/2023

Prothena Adds Ex-FDA Neuroscience Head to Board 05/17/2023

Attorney Sues FDA to Keep Name Off FDA-483 05/17/2023

Pharmedica CGMP Violations Result in Plant Shutdown 05/16/2023

Ipca Laboratories FDA-483 05/16/2023

FDA Issues with Sea-Long Medical Treatment Hoods 05/16/2023

Bespoke Gene Therapy Portfolio has 8 Diseases 05/16/2023

Let Compounders Help with Drug Shortages: Op-Ed 05/16/2023

Did Recarbrio Approval Break FDA Rules? 05/16/2023

Judge Hits Precision Lens with $487 Million Fine 05/16/2023

Abbott Spinal Stimulation Devices OK for Back Pain 05/16/2023

Comments on Electronic Systems Q&A Draft 05/16/2023

Byondis BLA on Breast Cancer Therapy Rejected 05/15/2023

Supreme Court Turns Down Skinny Label Case 05/15/2023

Split Vote on Sarepta Gene Therapy 05/15/2023

Pedicle Screw Bone Awl Cleared 05/15/2023

Guide on Reporting Animal Drug Shortages 05/15/2023

Orphan Status for Pyxis Pancreatic Cancer Therapy 05/12/2023

Cordis Class 1 Recall of Angioguard System 05/12/2023

Congress Urges More FDA Attention to Rare Diseases 05/12/2023

FDA Encourages Voluntary Device Shortage Notices 05/12/2023

Panel Backs Epinephrine Nasal Spray 05/12/2023

FDA Eases Blood Donor HIV Recommendations 05/11/2023

Cook Tracheostomy Introducer Recall is Class 1 05/11/2023

FDA OKs Rexulti for Alzheimer’s Agitation 05/11/2023

More Groups, Experts Back KEI Ad Music Petition 05/11/2023

FDA Planning for Future Public Health Issues 05/11/2023

Sibel Health Infant Monitor Cleared 05/11/2023

Complete Response on Bladder Cancer BLA 05/11/2023

PhRMA on FDA Negative Controls Workshop 05/11/2023

CRN Asks FDA to Reconsider Drug Preclusion 05/11/2023

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