FDA Archives - Page 90 of 220

3 minute read

CNS Pharmaceuticals Receives Approval From Competent Authority And Central Ethics Committee In Italy For Potentially Pivotal Global Trial Evaluating Berubicin For The Treatment Of GBM

April 6, 9:08 AM

Continued advancement of global patient enrollment with approvals and site activations in the U.S., Switzerland, France, Spain and Italy Enrollment continuing to progress toward an interim analysis expected in

CNSP

2 minute read

Revolution Medicines To Present Preclinical Data At The Upcoming American Association For Cancer Research Annual Meeting 2023

By Happy Mohamed

April 6, 8:18 AM

Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, today announced the company and its collaborators will present preclinical data at

RVMD

1 minute read

InflaRx Scores FDA Emergency Use Nod For COVID Antibody

By Vandana Singh

April 5, 9:06 AM

InflaRx NV’s (NASDAQ:IFRX) stock is up Wednesday morning as the FDA granted emergency-use authorization to its monoclonal antibody for hospitalized COVID…

IFRX

2 minute read

Y-mAbs Announces First Patient Dosed In Phase 1 Clinical Trial Of GD2-SADA

By Happy Mohamed

April 5, 9:00 AM

Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (NASDAQ:YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic

YMAB

1 minute read

Virpax Reports On Progress Of Envelta; Dose Ranging Studies For Envelta In Both Rats And Dogs Were Recently Completed, And The Intranasal Administration Of Envelta Was Well-Tolerated And No Adverse Effects Were Observed

By Happy Mohamed

April 5, 9:00 AM

Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress

VRPX

2 minute read

Palisade Bio Announces Enrollment Of First Patient In Newsoara Phase 3 Clinical Trial Evaluating LB1148; Enrollment Triggers Milestone Payment, Financial Details Not Disclosed

By Happy Mohamed

April 5, 8:46 AM

Palisade Bio, Inc. (NASDAQ:PALI) ("Palisade" or the "Company"), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced today

PALI

4 minute read

Mirum Submits For European Approval Of LIVMARLI In Progressive Familial Intrahepatic Cholestasis

By Happy Mohamed

April 5, 8:42 AM

Marketing Authorization variation submitted for treatment of patients with progressive familial intrahepatic cholestasis (PFIC) two months of age and older; data supports treatment across the broadest range of genetic

MIRM

3 minute read

InflaRx Receives FDA Emergency Use Authorization For Gohibic For Treatment Of Critically Ill COVID-19 Patients

By Happy Mohamed

April 4, 3:07 PM

Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune response FDA granted EUA based on Phase III clinical trial

IFRX

2 minute read

Tiziana Life Sciences Announces Invitation For Podium Presentation Of Research On Intranasal Anti-CD3 mAb In Intracerebral Hemorrhage At The Annual American Academy Of Neurology Conference

By Happy Mohamed

April 4, 10:45 AM

Dr. Saef Izzy's data shows one-month behavioral outcomes improvement in model of intracerebral hemorrhage (hemorrhagic stroke) Modulation of neuroinflammation by inducing FoxP3+ Tregs appears to have beneficial

TLSA