Results For "U.S.-FDA"

207 News Found

Equipment | December 23, 2021

U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath

Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters

Drug Approval | December 23, 2021

U.S. FDA approves Novartis Leqvio to lower cholestrol

With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1

Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition

Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin

Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant

News | December 08, 2021

Healthium Medtech Sri City facility in AP gets U.S. FDA registration

This is the fourth facility from the company to receive this registration

Biotech | December 07, 2021

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects

Drug Approval | December 05, 2021

Morpen gets U.S. FDA approval for Fexofinadine

Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever

Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)

Drug Approval | November 30, 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal