Biotech - Spark Newswire

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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

Today, 10:01 PM

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

Why BioMarin Shares Are Plunging Today?

By Vandana Singh

Today, 10:01 PM

Biomarin Pharmaceutical Inc (NASDAQ: BMRN) shares are falling in reaction to positive data from BridgeBio Pharma Inc's (NASDAQ: BBIO) dwarfism drug, heating the competition.

BBIO

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

Today, 10:01 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

Today, 10:01 PM

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

JNJ

1 minute read

Clene’s Lead Amyotrophic Lateral Sclerosis Shows Improved Function, Slowed Disease Progression

By Vandana Singh

Today, 10:01 PM

Clene Inc (NASDAQ:CLNN) announced new results showing preserved ALS patient functional score (ALSFRS-R) and delayed time to clinical worsening from the…

CLNN

1 minute read

Investors Cheer Armata Pharma’s Encouraging Data From Lung Infection Candidate

By Vandana Singh

Today, 10:01 PM

Armata Pharmaceuticals Inc (NASDAQ:ARMP) announced positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02 for chronic pulmonary Pseudomonas aeruginosa infections in…

ARMP

1 minute read

BioCardia Outlines Detailed Cell Therapy Data From Heart Failure Study

By Vandana Singh

Today, 10:01 PM

BioCardia Inc (NASDAQ:BCDA) presented detailed echocardiography data from the roll-in cohort of the Phase 3 CardiAMP Cell Therapy Heart Failure Trial.…

BCDA

2 minute read

BridgeBio’s Dwarfism Candidate Shows Favorable Height Increase, Safety Profile

By Vandana Singh

Today, 10:01 PM

BridgeBio Pharma Inc (NASDAQ: BBIO) announced results from PROPEL2 Phase 2 trial of infigratinib in children with achondroplasia, a genetic condition affecting a protein in the body called the fibroblast growth factor receptor.

BBIO

1 minute read

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

By Vandana Singh

Today, 10:01 PM

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

4 minute read

New Study Evaluates The Use Of Masimo PVi As An Indicator Of Fluid Responsiveness To Guide Goal-Directed Fluid Therapy In Adult Neurosurgical Patients

By Happy Mohamed

Today, 10:01 PM

Researchers Found That Noninvasive, Continuous PVi Was Equally Effective in Guiding Fluid Management As Stroke Volume Variation (SVV), an Invasive Method Requiring an Arterial Line Masimo (NASDAQ:MASI) today

MASI