FDA - Spark Newswire

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FDA
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Galecto Reports Prelim. Topline Results From Trial Of Co.’s Inhaled Galectin-3 Inhibitor: ‘significantly reduced oxygen flow requirements and improved several biomarkers for lung and systemic inflammation, liver function, tissue damage and coagulation’

Today, 12:57 PM

GB0139 significantly reduced oxygen flow requirements and improved several biomarkers for lung and systemic inflammation, liver function, tissue damage and coagulation Data demonstrate potential of GB0139 in

GLTO

1 minute read

AstraZeneca’s Koselugo Gets European Nod To Treat Children With Multisystem Genetic Disorder

By Vandana Singh

Today, 12:57 PM

European Union has approved AstraZeneca plc’s (NASDAQ:AZN) Koselugo to treat children with neurofibromatosis type 1 and plexiform neurofibromas. Neurofibromatosis type…

AZN

2 minute read

Biocept Shares Spike Higher; Says To Collaborate With Quest Diagnostics To Provide Advanced NGS-Based Liquid Biopsy Testing For Patients With Lung Cancer

By Benzinga Newsdesk

Today, 12:57 PM

Biocept, Inc. (NASDAQ:BIOC), a leading provider of molecular diagnostic assays, products and services, today announced a collaboration with Quest Diagnostics (NYSE:DGX) to provide laboratory testing services to

BIOC

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FDA
News

Artelo Biosciences Highlights 2 Poster Presentations At 31st Annual International Cannabinoid Research Society Symposium, Jun. 22, 23

By Benzinga Newsdesk

Today, 12:57 PM

Artelo Biosciences, Inc. (NASDAQ: ARTL), a clinical stage biopharmaceutical company focused on the development of therapeutics that target lipid-signaling pathways, including the endocannabinoid system, today

ARTL

5 minute read

The Daily Biotech Pulse: Sanofi, Translate Bio Start Early Stage Seasonal Flu Vaccine Study, Dr. Reddy’s Launches Generic Vascepa, Halozyme Strikes Licensing Deal

By Shanthi Rexaline

Today, 12:57 PM

Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs June 21)

ABCL

2 minute read

Pacira BioSciences Reports EXPAREL Distribution Deal With Eurofarma In Latin America, No Terms Disclosed

By Benzinga Newsdesk

Today, 12:57 PM

Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that it has entered into a distribution agreement with

PCRX

1 minute read

FDA
News

Caladrius Biosciences Says To Assess Its CLBS201 CD34+ Cell Therapy In Diabetic Kidney Disease

By Benzinga Newsdesk

Today, 12:57 PM

Caladrius Biosciences, Inc. (NASDAQ:CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease,

CLBS

1 minute read

Fennec Pharma Stock Is Trading Higher As Pedmark Is Under FDA Review For Chemo-Induced Toxicity

By Vandana Singh

Today, 12:57 PM

The FDA has accepted for review Fennec Pharmaceuticals Inc’s (NASDAQ:FENC) resubmitted marketing application seeking approval for Pedmark (formulated sodium thiosulfate) to…

FENC

3 minute read

Lineage Cell Therapeutics To Submit Amendment To IND For OPC1 To Support A Phase 1 Trial To Evaluate Safety And Performance Of Neurgain Technologies Inc.’s Parenchymal Spinal Delivery System

By Bill Haddad

Today, 12:57 PM

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided an update on the clinical advancement of

LCTX

1 minute read

Fennec Pharmaceuticals Announces FDA Acceptance Of New Drug Application Resubmission For PEDMARK

By Bill Haddad

Today, 12:57 PM

Fennec Pharmaceuticals Inc. (NASDAQ:FENC, TSX:FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug

FENC