FDA Archives - Page 21 of 220

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FDA
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FDA Says Philips North America Is Recalling The Panorama 1.0T HFO Due To Risk Of Explosion During A Quench Procedure Caused By Excessive Pressure Buildup Of Helium Gas.

December 20, 2:46 PM

https://www.einnews.com/pr_news/676411596/philips-north-america-llc-recalls-panorama-1-0t-hfo-due-to-a-risk-of-explosion-during-a-quench-procedure-caused-by-excessive-pressure-buildup-of#:~:text=Reason%20for%20Recall,bui

PHG

1 minute read

Medtronic Issues Class I Recall For Its Surgical Navigation Software Due To Glitch

By Vandana Singh

December 20, 1:32 PM

Medtronic Plc (NYSE: MDT)

MDT

3 minute read

Tonix Pharmaceuticals Announces Statistically Significant And Clinically Meaningful Topline Results In Second Phase 3 Clinical Trial Of TNX-102 SL For The Management Of Fibromyalgia

By Benzinga Newsdesk

December 20, 11:31 AM

Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005) All six key secondary endpoints, including patient global impression,

TNXP

2 minute read

Creative Medical Technology Holdings Granted FDA Clearance To Begin Phase 1/2 Clinical Trial Of AlloStem For Addressing Chronic Lower Back Pain

By Benzinga Newsdesk

December 20, 10:37 AM

Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a biotechnology company has received clearance from the FDA to conduct a phase 1/2 clinical trial using their innovative StemSpine® treatment known as

CELZ

3 minute read

BrainStorm Issues 2023 Letter To Shareholders; Says Our Focus Remains To Align With The FDA On A Phase 3b Trial Design, As We Acknowledge That This Represents The Most Expedient Pathway To Approval

By Benzinga Newsdesk

December 20, 10:02 AM

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today issued a Letter to shareholders.Dear Shareholders,We remain steadfast in our

BCLI

2 minute read

E-cigarette Player Juul’s Latest Move: Submits FDA Application for Menthol Pods with Stringent Age Checks

By Vandana Singh

December 20, 9:53 AM

E-cigarette maker Juul Labs Inc. announced its latest move to secure approval from the FDA for its newly developed menthol-flavored pods.

2 minute read

Ascendis Pharma’s Growth Hormone Deficiency Candidate Outperforms in Phase 3 Trial

By Vandana Singh

December 19, 3:30 PM

Ascendis Pharma A/S (NASDAQ: ASND) released topline results from Phase 3 foresiGHt trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth

ASND

4 minute read

FDA Grants Priority Review To Xolair For Children And Adults With Food Allergies Based On National Institutes Of Health Phase III Study Results

By Benzinga Newsdesk

December 19, 10:42 AM

– If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure –– Interim analysis results from first-of-its-kind Phase III OUtMATCH study showed Xolair

RHHBY

4 minute read

Processa Pharmaceuticals Provides Interim Analysis From Ongoing Phase 1b Trial Of Next Generation Capecitabine Showing Improved Safety Over Capecitabine

By Benzinga Newsdesk

December 19, 10:05 AM

FDA acknowledges that NGC-Cap is a New Chemical Entity given the changes to metabolism and distribution of its major metabolite 5-FUInterim analysis of the NGC-Cap Phase 1b data shows improved safety, even with 5-FU

PCSA

3 minute read

Outlook Therapeutics Submits Special Protocol Assessment To FDA For Non-Inferiority Study Of ONS-5010; NORSE EIGHT Study On Track To Commence In Q1 2024

By Benzinga Newsdesk

December 19, 9:07 AM

NORSE EIGHT study on track to commence in Q1 2024Resubmission of ONS-5010 Biologics License Application (BLA) in the U.S. expected by the end of calendar year 2024ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook

OTLK