FDA Archives - Page 209 of 220

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AstraZeneca Announced Ultomiris Recommended for Approval in the EU by CHMP for the Treatment of Adults with Generalized Myasthenia Gravis

July 25, 4:53 AM

Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

AZN

2 minute read

AstraZeneca Announced Tezspire Recommended for EU Approval in Asthma

By Charles Gross

July 25, 4:51 AM

AstraZeneca's Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

AZN

1 minute read

FDA Clears iRhythm’s ZEUS System For Zio Watch Made In Partnership With Google’s Verily

By Vandana Singh

July 22, 10:55 AM

iRhythm Technologies Inc (NASDAQ:IRTC) has received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. …

GOOG

3 minute read

iRhythm Gains FDA Clearance For Its Clinically Integrated ZEUS System

By Benzinga Newsdesk

July 22, 8:31 AM

iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization

IRTC

1 minute read

FDA
News

Alimera Announces Pricing, Reimbursement Of Uveitis Indication Granted For ILUVIEN In France

By Benzinga Newsdesk

July 22, 8:07 AM

Alimera Sciences, Inc. (NASDAQ:ALIM) ("Alimera"), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining

ALIM

1 minute read

FDA
News

‘Potential fabrication in research images threatens key theory of Alzheimer’s disease’ -Science.org Report

By Benzinga Newsdesk

July 21, 3:42 PM

https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease

SAVA

1 minute read

FDA
News

New York Health Department: Testing Suggests Polio Virus In Found Case May Have Originated Outside Of U.S.

By Benzinga Newsdesk

July 21, 1:39 PM

-Reuters

SNY

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FDA
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New York Health Officials Report Polio Case, The First One In U.S. In Nearly A Decade.

By Benzinga Newsdesk

July 21, 1:35 PM

-Bloomberg

SPY

1 minute read

House Now Voting On Legislation That Would Enshrine Federal Protection Of Access To Contraceptives Without Government Restrictions Into Law

By Benzinga Newsdesk

July 21, 11:44 AM

https://twitter.com/CraigCaplan/status/1550143822281297920

AGRX

2 minute read

FDA
News

Molecular Partners Announces Publication In Nature Biotechnology Detailing Design And Mechanism Of Ensovibep DARPin Antiviral For SARS-CoV-2

By Benzinga Newsdesk

July 21, 11:30 AM

Molecular Partners AG ((SIX: MOLN, NASDAQ:MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, today announced the publication of key

MOLN