FDA Archives - Page 100 of 220

4 minute read

Reported Late Tuesday March 7, FDA Accepts Mesoblast’s Resubmission Of The Biologic License Application For Remestemcel-L In Children With Steroid-Refractory Acute Graft Versus Host Disease As A Complete Response And Sets Goal Date Of August 2, 2023

March 8, 1:30 AM

Mesoblast Limited (NASDAQ:MESO, ASX:MSB)))), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration's (FDA) Office of Therapeutic

MESO

2 minute read

FDA’s Regulatory Delay is The Reason For Novavax, Lucira Health’s Failure: WSJ Report

By Vandana Singh

March 7, 2:29 PM

Failures of Covid vaccine maker Novavax Inc (NASDAQ: NVAX) and diagnostic start-up Lucira Health Inc (NASDAQ: LHDX) show that companies often succeed or fail, owing to the whims of the government.&nb

LHDX

2 minute read

‘Qualigen Peer-Reviewed Journal Article Out Titled “The Potent G-Quadruplex-Binding Compound QN-302 Downregulates S100p Gene Expression In Cells And In An In Vivo Model Of Pancreatic Cancer”‘

By Happy Mohamed

March 7, 12:30 PM

https://www.mdpi.com/1420-3049/28/6/2452 Abstract The naphthalene diimide compound QN-302, designed to bind to G-quadruplex DNA sequences within the promoter regions of cancer-related genes, has high anti-proliferative

QGEN

3 minute read

Dupixent Application For Treatment Of Chronic Spontaneous Urticaria In Adults And Adolescents Accepted For FDA Review

By Happy Mohamed

March 7, 2:19 AM

Dupixent® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review More than 300,000 people in the

REGN

3 minute read

FDA
News

Reported Late Monday March 06, BioMarin Provides Update On FDA Review Of ROCTAVIAN Gene Therapy For Adults With Severe Hemophilia A; FDA Extends PDUFA Target Action Date To June 30, 2023

By Happy Mohamed

March 7, 2:06 AM

FDA Extends PDUFA Target Action Date to June 30, 2023 SAN RAFAEL, Calif., March 6, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ:BMRN), a global biotechnology company dedicated to transforming

BMRN

1 minute read

On March 6, 2023, ReWalk Robotics Announced That Its ReWalk Personal Exoskeleton Technology Received Clearance From The U.S. Food And Drug Administration For Use On Stairs And Curbs In The United States; Shares Spike Higher

By Happy Mohamed

March 6, 1:29 PM

- Form 8 Filing

RWLK

1 minute read

‘Johnson & Johnson Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy Of Macitentan And Tadalafil Significantly Improves Pulmonary Hemodynamics Versus Monotherapy In Patients With Pulmonary Arterial Hypertension’

By Happy Mohamed

March 6, 12:54 PM

https://johnsonandjohnson.gcs-web.com/static-files/3137d414-8b4a-432d-bee1-16af33aa8233

JNJ

1 minute read

Eisai-Biogen Seek Complete FDA Approval For Its Second Alzheimer’s Treatment

By Vandana Singh

March 6, 11:46 AM

The FDA has accepted Eisai Co Ltd (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection,…

BIIB

1 minute read

FDA
News

Cantex and Miami Cancer Institute Announce FDA Clearance for a Clinical Trial Investigating Azeliragon Combined with Stereotactic Radiosurgery for the Treatment of Brain Metastases

By Benzinga Newsdesk

March 6, 9:03 AM

Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Baptist Health Miami Cancer

VTVT

1 minute read

FDA Accepted Eisai-Biogen’s Supplemental Biologics License Application For Leqembi (Lecanemab-IRMB) 100 mg/ml Injection For Intravenous Use, Supporting The Conversion Of The Accelerated Approval Of Leqembi To A Traditional Approval

By Benzinga Newsdesk

March 6, 4:45 AM

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application

BIIB