<< Prev  6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Next >>

Multiple Violations at Vitang Technology 06/20/2023

Professor Calls for Alzheimer’s Drugs REMS 06/20/2023

FDA Grants, Denies BI Spiriva Petition 06/20/2023

New Areas of ICH Harmonization 06/20/2023

FDA Extends Neffy NDA Review 06/20/2023

Surmodics Drug-Coated Balloon Approved 06/20/2023

FDA Reports on State of Pharmaceutical Quality 06/20/2023

Review Extended on GSK’s Momelotinib 06/16/2023

Philips Safety Alert on Azurion/Allura Devices 06/16/2023

FDA Posts 483 of iRhythm’s CA Facility 06/16/2023

Emigality Misses Superiority in Clinical Trial 06/16/2023

Columvi Accelerated Approval for Lymphoma 06/16/2023

FDA Backs Monovalent XBB.1.5 Covid Vaccine 06/16/2023

Reps. Introduce Drug Labeling Bill 06/15/2023

Panel Backs Monovalent XBB Variant Covid Vaccine 06/15/2023

AI/ML Challenges in Precision Medicine: FDA Paper 06/15/2023

Corvus Wants FDA Meeting on CPI-818 Trial 06/15/2023

Conditional Approval for ‘Marginal’ New Drugs: Avorn 06/15/2023

FDA OKs Amendment to Uproleselan Trial 06/15/2023

Public Citizen Urges FDA to Reject Duchenne BLA 06/15/2023

American Lab’s Bowel Disease Assay Cleared 06/15/2023

FDA Partial Hold on Mersana Trials 06/15/2023

FDA to Decide Florida Drug Import by 10/31 06/14/2023

Pfizer Warns of Bicillin Shortages 06/14/2023

CDER Supports C-Path Pancreatic Markers 06/14/2023

FDA Patient Medication Information Highlighted 06/14/2023

2seventy bio Leukemia Trial Paused 06/14/2023

Starton OK’d for Multiple Myeloma Trial 06/14/2023

Device Software Submission Guidance 06/13/2023

A&Z Selling Illegal New Kids’ Drug 06/13/2023

Recorlev Web Pages ‘False or Misleading’: FDA 06/13/2023

FDA Rare Disease ARC Program Update 06/13/2023

OTC Erectile Dysfunction Gel Authorized in U.S. 06/13/2023

BIO on FDA Data, Technology Plan 06/13/2023

More Data Needed for Neffy ANDA: Viatris 06/13/2023

Wearable Smart Thermometer Recalled 06/12/2023

Phathom Pharma Resubmits Vonoprazan NDA 06/12/2023

FDA Backs New Covid Vaccine with XBB Variant 06/12/2023

Info Collection on MedSun Device Reporting 06/12/2023

Collection on Device Premarket Notification Revised 06/12/2023

MAPP on ANDA Facility Deficiency Reclassifiaction 06/12/2023

Linzess Approved for Pediatric Constipation 06/12/2023

FDA Needs New Policies for AI: Gottlieb 06/09/2023

FDA Alert on Oxygenator Recall 06/09/2023

Panel Backs Full Approval of Alzheimer’s Drug 06/09/2023

SurGenTec Sacroiliac Joint Fusion Device Cleared 06/09/2023

Bipartisan Bill on Provisional FDA Approvals 06/09/2023

FDA Sees Need to Better Address Drug Shortages 06/08/2023

Oral Contraceptive Drug Interaction Guidance 06/08/2023

Avita Skin Defect Device Get Expanded Use 06/08/2023

FDA Taps Murphy to Head Generic Drugs Office 06/08/2023

Panel Backs RSV Monoclonal Antibody 06/08/2023

Create One PPI Guidance for all Products: Novartis 06/08/2023

Assessing GDUFA User Fees Guidance 06/08/2023

FDA Ups Pediatric Exclusivity Requirements: Attorneys 06/08/2023

CBER Post-Covid Transition Information 06/07/2023

Eisai/Biogen Alzheimer’s Drug Effective: FDA 06/07/2023

Bioresearch Monitoring Issues in Mazhar Trials 06/07/2023

PMI ‘Major Change’ in Drug Labeling: Attorneys 06/07/2023

FibroGen’s Pamrevlumab Fails Phase 3 06/07/2023

AdvaMed Recommendations for Patient Preference 06/07/2023

Adderall Shortage Process “Muddy, Obscure”: Wyden 06/06/2023

Updated ICH Good Clinical Practice Guidance 06/06/2023

Multiple Violations at Steiner Biotechnology 06/06/2023

iRhythm Technologies Cited for Unapproved Device 06/06/2023

Norwich Sues FDA Over Rifaximin ANDA 06/06/2023

FDAers Assess Frontline Renal Cancer Treatments 06/06/2023

Sun Pharma India Facility on Import Alert 06/06/2023

FDA Struggles to Recruit in Wake of Retirements 06/06/2023

Abiomed Recalls Impella Heart Pump 06/05/2023

FDA on Pneumatic Tourniquet Cuff Shortage 06/05/2023

FDA Lifts Hold on Foghorn Leukemia Drug 06/05/2023

Draeger Recalls Ventilator Sets/Tubing 06/05/2023

Intas Pharma on Import Alert After Inspection 06/05/2023

Guidance on ANDA Cover Letter Attachments 06/05/2023

FDA Lifts Hold on Multiple Myeloma Drug 06/02/2023

Durbin Urges FDA to Act More on Cancer Drug Shortage 06/02/2023

Therapeutic Protein Drug Interaction Assessment Guide 06/02/2023

Guidance on Device Pre-Submission Meetings 06/02/2023

Interstitial Cystitis/Bladder Pain Syndrome Guidance 06/02/2023

FDA Withdraws 8 No-Longer-Marketed ANDAs 06/01/2023

FDA OKs Pfizer Abrysvo RSV Vaccine 06/01/2023

Migraine Drug Development Guidance 06/01/2023

AstraZeneca Ends Brazikumab Development 06/01/2023

Balance AI Optimism and Pessimism: Califf 06/01/2023

Roche/Genentech Suggestions for nAMD Guidance 06/01/2023

Patient Access to At-Home Technologies 06/01/2023

Doc Bought Oncology Meds to Sell for Profit: DoJ 06/01/2023

FDA Clears Ezra Flash AI for MRI Quality 06/01/2023

CDER Drug Policy Guru Heads to Morgan Lewis 06/01/2023

Clinical Hold on PepGen IND Application 05/31/2023

Precision BioSciences to Meet with FDA on Azer-Cel 05/31/2023

Groups Want Regulation of Lab-Developed Tests 05/31/2023

Junshi Bio Inspection to Advance Toripalimab BLA 05/31/2023

FDA to Permit In-Person End-of-Phase 2 Meetings 05/31/2023

FDA Alert on Compounded Semaglutide 05/31/2023

CDER Risk, Safety Report for 2022 Issued 05/31/2023

FDA Limited in Managing Drug Shortages: Pazdur 05/31/2023

FDA Proposes 1-Page Patient Medication Information 05/30/2023

Violations at Advanced Compounding Solutions 05/30/2023

<< Prev  6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25  Next >>