FDA - Spark Newswire

3 minute read

FDA
News

Ascendis Pharma Says Target Enrollment Achieved In Phase 3 PaTHway Trial Of TransCon

Today, 8:42 PM

Ascendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create new product candidates that address unmet medical needs, today announced it has reached the

ASND

2 minute read

FDA
News

Longeveron Announces First Patient Treated In Phase 2b Hypoplastic Left Hearth Syndrome Clinical Study

By Benzinga Newsdesk

Today, 8:42 PM

Longeveron Inc. (NASDAQ:LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced

LGVN

1 minute read

CytoSorbents Shares Are Trading Higher On Launch Of Trial On Ticagrelor Removal During Cardiothoracic Surgery

By Vandana Singh

Today, 8:42 PM

CytoSorbents Corporation (NASDAQ:CTSO) receives full FDA approval to conduct the STAR-T trial in the U.S. to support regulatory clearance of DrugSorb…

AZN

2 minute read

Knight Therapeutics Announces Health Canada Approval For NERLYNX To Treat HER2-Positive Metastatic Breast Cancer

By Bill Haddad

Today, 8:42 PM

Knight Therapeutics Inc. (TSX:GUD), ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) in combination with capecitabine

PBYI

2 minute read

Soleno Therapeutics Says On Jul. 2 Received Official meeting Minutes From Type B FDA Meeting; FDA Continued To Assert That Based On Data, Additional Trial Is Necessary For NDA But Encouraged Co. To Submit Available Data

By Bill Haddad

Today, 8:42 PM

Soleno Therapeutics, Inc. ("Soleno") (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following a recent

SLNO

1 minute read

Provention Bio’s Teplizumab Application Receives CRL For Type-1 Diabetes; Stock Drops

By Vandana Singh

Today, 8:42 PM

The FDA has issued a Complete Response Letter (CRL) to Provention Bio Inc’s (NASDAQ:PRVB) teplizumab marketing application seeking approval for the delay…

PRVB

1 minute read

Iveric Bio Stock Jumps Higher On SPA Agreement From FDA For Zimura Study In Geographic Atrophy

By Vandana Singh

Today, 8:42 PM

Iveric Bio Inc (NASDAQ:ISEE) has received written agreement from the FDA under a Special Protocol Assessment (SPA) for the overall design…

ISEE

1 minute read

Ocugen Preps US Filings For COVID-19 Vaccine As New Data Shows Overall Efficacy Of Around 79%

By Vandana Singh

Today, 8:42 PM

Armed with new data from its development partner Bharat Biotech, Ocugen Inc (NASDAQ: OCGN) plans to press ahead with plans to file for approval of their COVID-19 vaccine, Covaxin, in the U.S. and Canada.

OCGN

1 minute read

Innate Pharma To Stop COVID-19 Trial With Avdoralimab After Mid-Stage Study Disappoints

By Vandana Singh

Today, 8:42 PM

Innate Pharma SA (NASDAQ:IPHA) has announced its Phase 2 FORCE trial evaluating avdoralimab in COVID-19 patients with severe pneumonia did…

IPHA

3 minute read

Provention Bio Receives Complete Response Letter To Biologics License Application For Teplizumab

By Bill Haddad

Today, 8:42 PM

Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete

PRVB