FDA - Spark Newswire

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FDA
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uniQure Reports 52-Week Clinical Data From HOPE-B Trial Of Hemophilia B Treatment Candidate: Showed ‘Sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal in full study population one year following…’

Today, 1:08 PM

~ Sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal in full study population one year following a single administration of etranacogene dezaparvovec ~ ~ Held pre-BLA

QURE

1 minute read

Caladrius Bioscience To Start Testing Its CD34+ Cell Therapy in Diabetic Kidney Disease

By Vandana Singh

Today, 1:08 PM

The FDA has signed off Caladrius Bioscience Inc’s (NASDAQ:CLBS) investigational new drug application for the study of CLBS201 for the treatment…

CLBS

1 minute read

Incyte Shares See Volume; Traders Circulate FDA Release Considering Delaying Decision On Co’s Retifanlumab For Treatment Of Advanced Or Metastatic SCAC

By Benzinga Newsdesk

Today, 1:08 PM

https://www.fda.gov/media/150247/download

INCY

1 minute read

Lineage’s Spinal Cord Injury Cell Therapy Return To Clinical Testing

By Vandana Singh

Today, 1:08 PM

Following feedback received from the FDA, Lineage Cell Therapeutics Inc (NYSE:LCTX) will submit an amendment to its Investigational New Drug…

LCTX

2 minute read

FDA
News

BioSig Technologies Says Signal Processing System For Electrophysiology Featured In 2 Clinical, Scientific Presentations At Heart Rhythm 2021 Convention

By Benzinga Newsdesk

Today, 1:08 PM

ioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity

BSGM

2 minute read

Adial Pharmaceuticals Shares Spike Higher; Co Says Plans To Enter Genetic Testing Market Following Allowance Of U.S. Patent For Genetic Diagnostic Test

By Benzinga Newsdesk

Today, 1:08 PM

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)))), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced plans

ADIL

2 minute read

ADC Therapeutics Highlights Interim Results From Pivotal Phase 2 Clinical Trial Of Camidanlumab Tesirine Presented At 16th Annual International Conference On Malignant Lymphoma

By Benzinga Newsdesk

Today, 1:08 PM

ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, announced today that

ADCT

2 minute read

JanOne Shares Spike Higher; Says Selects Regulatory Partner For Phase 2b Trial As Investigational Plan Is Prepared for FDA Filing

By Benzinga Newsdesk

Today, 1:08 PM

JanOne Inc. (NASDAQ:JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, today announced its selection of Avania as its

JAN