No Picture
News

Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

NDA Supported by Data from Expansive Clinical Development Program Demonstrating Tenapanor’s use as Foundational TherapyPDUFA Goal Date – April 29, 2021

FREMONT, Calif., Sept. 15, 2020 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical … […]

No Picture
News

BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

FDA Introduces New Recommendation for 2-Year Annualized Bleeding Rate (ABR) as Primary Endpoint for Ongoing Phase 3 Study 270-301Company Committed to Working with FDA to Align on Next Steps to Obtain Approval

SAN RAFAEL, Calif., Aug. 19, 2020 /PRNews… […]

No Picture
News

ANA Therapeutics Announces U.S. FDA Clearance Of IND Application To Initiate Clinical Trial Of Niclosamide In COVID-19 Patients

ANA Therapeutics has raised more than $5 million to develop niclosamide as a COVID-19 treatment

FOSTER CITY, Calif., Aug. 4, 2020 /PRNewswire/ — ANA Therapeutics (ANA), a Silicon Valley-based biotech start-up announced today that the U.S. Food and D… […]

No Picture
News

FDA Grants Emergency Use Authorization to VitalConnect for Cardiac Monitoring in COVID-19 Patients

VitalPatch? wearable biosensor can monitor for heart-related side effects of Hydroxychloroquine and other COVID-19 treatments

SAN JOSE, Calif., May 5, 2020 /PRNewswire/ –?VitalConnect?, Inc., a leader in wearable biosensor technology, announced it w… […]

No Picture
News

BioMarin’s Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA with Review Action Date of August 21, 2020

No Advisory Committee Meeting Currently Planned to Review the ApplicationIf approved, 1st Gene Therapy in U.S. for the Treatment of Any Type of HemophiliaFDA Also Accepts Premarket Approval (PMA) Application for Companion Diagnostic Test, a 1st for a G… […]

No Picture
News

VistaGen Therapeutics Receives FDA Clearance of IND for Phase 2 Clinical Study of AV-101 as a Potential Treatment of Dyskinesia in Parkinson’s Disease Patients

Company also Receives a Notice of Allowance from the USPTO for a New AV-101 U.S. Patent for Treatment of Dyskinesia Induced by Levodopa Therapy

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2020 /PRNewswire/ –?VistaGen Therapeutics (NASDAQ: VTGN), a clinic… […]