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Philips Recalls Faulty Ventilators, FDA Identifies Dust Issue As ‘Most Serious’

By Vandana Singh
August 15, 8:57 AM
Koninklijke Philips N.V. (NYSE: PHG) is recalling several ventilators after detecting dust and dirt from the environment in the air path

PHG

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FDA Approves Pfizer’s Blood Cancer Therapy For Heavily Pretreated Patients

By Vandana Singh
August 15, 8:56 AM
The FDA granted accelerated approval to Pfizer Inc's (NYSE: PFE) Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at 

PFE

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Pfizer’s ELREXFIO Receives U.S. FDA Accelerated Approval For Relapsed Or Refractory Multiple Myeloma

By Happy Mohamed
August 14, 2:09 PM
The approval of ELREXFIO (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study ELREXFIO is the first off-the-shelf (ready-to-use) fixed-dose

PFE

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2 minute read
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ENDRA Life Sciences Submits De Novo Request For Its TAEUS System Liver Fat Application To The U.S. FDA

By Happy Mohamed
August 14, 1:30 PM
Announces Positive Topline Data from Clinical Studies Comparing TAEUS with MRI-PDFF ENDRA Life Sciences Inc.(NASDAQ:NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®),

NDRA

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3 minute read
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FDA Accepts MyMD Pharmaceuticals’ Investigational New Drug Application For Phase 2 Study Of Oral TNF-α Inhibitor MYMD-1 In Rheumatoid Arthritis

By Happy Mohamed
August 14, 9:06 AM
- Next-generation and first oral TNF-α inhibitor, which completed Phase 2 study for age-related condition sarcopenia, represents a potentially groundbreaking advance in the treatment of RA and disruption of

MYMD

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Ra Medical Systems Announces Allowance Of New Closure Device Patent; First Patent Out Of Six Applications On File For LockeT Product

By Happy Mohamed
August 14, 8:47 AM
First patent out of six applications on file for LockeT product FORT MILL, SC / ACCESSWIRE / August 14, 2023 / Ra Medical Systems, Inc. (NYSE:RMED) today announced that it has received notification of

RMED

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Why Is Galera Therapeutics Stock Sinking Today?

By Vandana Singh
August 10, 9:45 AM
The FDA issued a Complete Response Letter (CRL) to Galera Therapeutics Inc's (NASDAQ: GRTX) New Drug Application (NDA) for avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing 

GRTX

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4 minute read
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Galera Receives Complete Response Letter From U.S. FDA for Avasopasem Manganese; The Co Intends To Request A Type A Meeting With The FDA To Understand The FDA’s Rationale For Its Decision

By Happy Mohamed
August 9, 4:35 PM
The Company remains committed to its goal of bringing avasopasem to patients and intends to meet with FDA as soon as possible to discuss potential next steps   Galera will take actions to extend its cash runway and

GRTX

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4 minute read
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Terns Achieves Primary Endpoint And All Secondary Endpoints In Phase 2a DUET Trial Of THR-β Agonist TERN-501 In NASH

By Happy Mohamed
August 8, 5:42 PM
TERN-501 demonstrated dose dependent MRI-PDFF reductions at Week 12 as a once-daily, low dose, and combinable oral therapy   TERN-501 (6mg) showed statistically significant mean relative liver fat content reduction

TERN

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Boston Scientific Receives FDA Approval For The POLARx Cryoablation System

By Happy Mohamed
August 8, 5:06 PM
First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific

BSX

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