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FDA Approves Janssen’s Talvey 08/10/2023

Underrepresented Population Data Guidance 08/10/2023

FDA Updates Regulatory Science Device Catalog 08/10/2023

Cardiosave Intra-aortic Balloon Pumps Recalled 08/10/2023

PhRMA, Others Boost FDA Discussion Paper on AI 08/10/2023

Guide on QTc Labeling Information 08/09/2023

FDA OKs Aspen IND for Parkinson’s Therapy 08/09/2023

FDA to Review Vitaris/Mapi GA Depot NDA 08/09/2023

Doctors, Health Systems Should Test Generics: Article 08/09/2023

Law Settles ‘Active Ingredient’ Debate 08/09/2023

5 Pharmas Settle Improper Reimbursement Case 08/09/2023

FDA Grants Traditional Approval to Gavreto 08/09/2023

Galera Gets ‘Complete Response’ on Mucositis Drug 08/09/2023

Curiteva Navigation Instruments for Fusion Cleared 08/08/2023

‘Less Rigorous Standards’ in Drug Approvals: Study 08/08/2023

FDA Modernizing GCP Guidelines: Attorneys 08/08/2023

FDA Warns Overseas OTC Manufacturers 08/08/2023

CBER Allowing Device ‘In-Person’ Meetings 08/08/2023

BIO Supports FDA’s AI/ML Discussion 08/08/2023

Wegovy Hits Trial MACE Goal 08/08/2023

FDA OKs Boston Scientific Cryoablation Device 08/08/2023

QTc Labeling Information Guidance 08/08/2023

Dräger Recalls Carina Ventilators 08/07/2023

Sage Postpartum Depression Oral Drug Approved 08/07/2023

Draft Guide on Cosmetic Registration/Listing 08/07/2023

Astellas Eye Drug Approved by FDA 08/07/2023

FDA Clears Abbott’s Hematology Device 08/07/2023

Regeneron Prostate Cancer Trial Stops Enrollment 08/04/2023

FDA Floats AI Modeling to Help Assess Drug Safety 08/04/2023

Nitrosamine Acceptable Intake Limits Guide 08/04/2023

Mesoblast Sent Another Complete Response Letter 08/04/2023

Biosense Webster New Label on Cardiac Ablators 08/04/2023

FDA Floats Food-Animal Antibiotic Use Group 08/03/2023

Imeka Brain White Matter Imaging Cleared 08/03/2023

DSCSA Can Lead to Drug Shortages: Reps 08/03/2023

DSCSA Waiver, Exception, Exemption Guidance 08/03/2023

WLF Claims Win In Lexapro Case Dismissal 08/03/2023

CDER into Bispecific Antibody Research, Application 08/03/2023

Regeneron Responding to Eylea ‘Complete Response’ 08/03/2023

RenatiLabs Illegally Marketing WJMAX 08/02/2023

FDA Warns Centaur on CGMP Issues 08/02/2023

Advancing RWE Program Deadline Coming 08/02/2023

PEPFAR Antiretroviral Drug Guidance 08/02/2023

Broader Scientific Topics for Advisory Panels: Bumpus 08/02/2023

Decentralized Clinical Trial Comments 08/02/2023

Baxter Recalls SIGMA Infusion Pumps 08/01/2023

FDA Fast Tracks Invectys IVS-3001 08/01/2023

Lupin Recalls 2 Lots of Tydemy Contraceptive 08/01/2023

FDA, DEA Steps to Ease Rx Stimulant Shortage 08/01/2023

FDA Warns Intas About Multiple Violations 08/01/2023

Iso-Tex Diagnostics CGMP Issues 08/01/2023

CGMP Violations at Baxter India Facility 08/01/2023

Teleflex QuikClot Device Expanded Use Cleared 08/01/2023

GSK Wins Expanded Use for Jemperli 07/31/2023

Senate Bill Introduced on Drug Shortages 07/31/2023

FDA Expands Device TAP Pilot 07/31/2023

Citius Pharma Gets Complete Response Letter 07/31/2023

Abbott Withdraws Trifecta Heart Valves 07/31/2023

GE Recalls TruSignal SpO2 Sensors 07/28/2023

FDA, Switzerland Recognizing Each Other's Inspections 07/28/2023

FDA, EMA Collaborate on Post-Approval Changes 07/28/2023

FDA Not Yet Implementing OTC Drug Reforms: GAO 07/28/2023

Opioid Disorder Innovative Devices 07/27/2023

Compliance Woes at Wegovy Syringe Plant 07/27/2023

FDA Won’t Review Toriluzole NDA 07/27/2023

RFK, Jr. for FDA or CDC: DeSantis 07/27/2023

Drug Shortage Legislative Fix Introduced 07/27/2023

Merck Pneumococcal Vaccine Hits Phase 3 Marks 07/27/2023

House Delays FDA Budget Floor Vote 07/27/2023

UltraSight Ultrasound Guidance Software Cleared 07/27/2023

Fentanyl Detection Kit Gains Clearance 07/26/2023

Alert Update on Vessel Occlusion CADt Devices 07/26/2023

Panel to Review BrainStorm ALS Submission 07/26/2023

Integrating ORA in Centers Has Risks: Analysis 07/26/2023

Recall Unapproved Phenobarb Products: Sun 07/26/2023

Central Admixture FDA-483 07/26/2023

FDA Hits Medical Device ‘Intended Use Creep’ 07/26/2023

Voluntary Consensus Standards Guidance 07/26/2023

Abbott Recalls Amplatzer Delivery Sheath 07/26/2023

Defender Pharma NDA for Scopolamine Gel 07/26/2023

Beckman Coulter Chemistry Analyzer Cleared 07/25/2023

Stratus Illegally Marketing Biologics: FDA 07/25/2023

FDA Denies 2 Vanda Tasimelteon Petitions 07/25/2023

CDRH Adds Device Sterilization Standards 07/25/2023

FDA Expanding CURE ID 07/25/2023

12 Catalent Inspection Observations 07/25/2023

FDA Told: ‘Generally Accepted’ Often Isn’t 07/25/2023

Dismissal Sought in FDA-483 Anonymity Suit 07/25/2023

3rd Circuit Flunks FDA Again Over Illegal Generics 07/25/2023

FDA Downplays Impact After Pfizer Tornado 07/24/2023

ICH Mutagenic Impurities Drug Guidance 07/24/2023

FDA Spending Bill Will See Veto: White House 07/24/2023

Horizon Misses on Lupus Phase 2 Endpoint 07/24/2023

Nesa Medtech Fibroid Mapping App Cleared 07/24/2023

FDA OKs Verrica NDA for Molluscum Topical 07/24/2023

ADC Therapeutics Discontinues Phase 2 Trial 07/21/2023

Bufferin NDA Withdrawn by FDA 07/21/2023

FDA OKs Emergent’s Anthrax Vaccine 07/21/2023

Peter Stoll Guilty on Medical Device Felony Count 07/21/2023

BIO Backs Rare Disease Endpoint Pilot 07/21/2023

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