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Breakthrough Status for Brixton Coolio 11/13/2023

Neurocrine Bio Stops 2 Develoment Programs 11/10/2023

Consent Decree Against Drug Distributor 11/10/2023

Covid Broke Vaccine Reporting System: BMJ 11/10/2023

FDA De Novo for Owlet Dream Sock 11/10/2023

Samsung Seeks Interchangeable Humira Biosimilar 11/10/2023

CDER Quality Office Reorganizing Next Year 11/09/2023

BD Mesh Products Alert on Breast Surgery 11/09/2023

Brochure Overstates Phexxi Benefits: OPDP 11/09/2023

FDA Updates Keytruda Gastric Cancer Indication 11/09/2023

Blood Storage Container is Class 2 11/09/2023

Takeda’s Adzynma Approved by FDA 11/09/2023

Cyltezo Exclusivity End Dates Recommended 11/09/2023

FDA Approves Recor Paradise System 11/08/2023

Don’t Approve Amryt’s Filsuvez NDA: Petition 11/08/2023

Former Reviewer McGarry Joins Greenleaf Health 11/08/2023

Rexulti Ads ‘False and Misleading’: OPDP 11/08/2023

Lilly Obesity Drug Gains FDA Approval 11/08/2023

Support for Convalescent Plasma Registries 11/08/2023

Democrats Introduce Anti Pay-for-Delay Bill 11/08/2023

Guide on Real-Time Oncology Reviews 11/08/2023

14 Observations in Kilitch India FDA-483 11/07/2023

Improve Cell, Gene Manufacturing Guidance: ISCT 11/07/2023

FTC Challenges Patent Listings in Orange Book 11/07/2023

Law Blog Faults FDA on Remote ‘Evaluations’ 11/07/2023

Neurotris Illegally Marketing Devices: FDA 11/07/2023

Real-Time Oncology Review Guidance 11/07/2023

Bill Seeks to Shift Drug Making to U.S. 11/07/2023

Covid Container Closure Guidance Still Effective 11/07/2023

J&J Plans 2024 Surgery Robot IDE Trials 11/07/2023

One-Third of BTD Requests Granted: Analysis 11/07/2023

Orphan Status for Breast Cancer Radiotherapy 11/06/2023

Guide on ‘Item Response Theory’ Clinical Data 11/06/2023

Guide on Device Export Certifications 11/06/2023

CDRH Endorses Device Cybersecurity Standard 11/06/2023

Petition Seeks to Block Vigabatrin Exclusivity 11/06/2023

Submitting PRO Data in Cancer Trials Guide 11/03/2023

House Oversight Panel Probes Drug Shortages 11/03/2023

Supernus Parkinson’s Off Episodes NDA Refiled 11/03/2023

Empatica Adds 2 Biomarkers to Monitoring Device 11/03/2023

FDA/Moderna ‘Revolving Door’ Analyzed 11/02/2023

Lilly Sees Alzheimer’s Drug Decision Delay 11/02/2023

Fix Pulse Oximeter Biases, 25 State AGs Tell FDA 11/02/2023

FDA Seeking Diabetes DHT Info 11/02/2023

FDA OKs Abbott HPV Diagnostic Test 11/02/2023

Monoclonal Antibody Manufacturing Changes Research 11/02/2023

I-Mab Gets Breakthrough for Nephropathy 11/02/2023

House GOPers ‘Concerned’ About FDA Lab Safety 11/02/2023

FDA Continues Device Supplement Guidance 11/01/2023

Why Are FDA-483 Observations the Same? 11/01/2023

Panel Backs Sickle Cell Gene Therapy Safety 11/01/2023

FDA Expects Increasing Cannabis Research 11/01/2023

Unlicensed Wholesaler Sentenced to Prison 11/01/2023

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

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