FDA Archives - Page 200 of 220

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ReShape Lifesciences Shares Soar As FDA Announced Clearance To GIBI HD Calibration Tubes In Weight Loss Procedures

August 10, 12:42 PM

The U.S. Food and Drug Administration (FDA) has announced 510(k) clearance to ReShape Lifesciences’ (NASDAQ: RSLS) Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube for use in gastric and bariatric surgical procedures.

RSLS

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ReShape Lifesciences Receives FDA 510(k) Clearance For GIBI HD Calibration Tubes For Use In Gastric and Bariatric Procedures

By Benzinga Newsdesk

August 10, 12:06 PM

New Calibration Tubes, in Three Sizes, Will Simplify Gastric and Bariatric Procedures Including Laparoscopic Sleeve Gastrectomy, Gastric Bypass and Gastric Banding Company to Introduce Product at IFSO 2022 World

RSLS

1 minute read

Lexaria Gets FDA’s Positive Feedback On Pre-Clinical Trial Of Hypertension Candidate

By Ragothaman Srinivasan

August 10, 11:36 AM

Lexaria Bioscience Corp. (NASDAQ: LEXX) announced that it has received a positive full written response from the Food and Drug Administration (FDA) from its pre-Investigational New Drug meeting regarding DehydraTECH-CBD for the treatment of hypertension.

LEXX

4 minute read

Biotech Daily: Cancer Causing Impurities In Merck’s Diabetic Drug, Vir Bio-GSK Shun FDA Submission Plans For COVID-19 Treatment, Aethlon’s Monkeypox Trial

By Vandana Singh

August 10, 11:33 AM

Here's a roundup of top developments in the biotech space over the last 24 hours:

ADMP

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FDA
News

Aridis Says Pan-Coronavirus, Inhaled Monoclonal Antibody Cocktail AR-701 Is Protective In Non-Human Primates

By Benzinga Newsdesk

August 10, 8:33 AM

Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that inhaled

ARDS

2 minute read

Volition Announces U.S. Clinical Study For Neutrophil Extracellular Traps

By Benzinga Newsdesk

August 10, 8:12 AM

VolitionRx Limited (NYSE:VNRX) ("Volition"), a multi-national epigenetics company, has announced a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of

VNRX

1 minute read

To Avoid Supply Crunch, FDA Temporarily Allows Higher Impurity Levels In Merck’s Diabetes Drug: Report

By Vandana Singh

August 10, 7:43 AM

The FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 or NTTP, in certain samples of Merck & Co Inc's (NYSE: MRK) type 2 diabetes drug Januvia/Janumet (sitagliptin).

MRK