Tag: FDA

May 6, 2019

Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel™

Zynerba Pharmaceuticals (NASDAQ:ZYNE) has announced that the US Food and Drug Administration (FDA) has given fast track designation for the...
April 30, 2019

BioVie Shares Results on Phase 2a Clinical Trial

BioVie shared top-line results for its Phase 2a clinical trial of BIV201 in patients with refractory ascites due to advanced liver cirrhosis.
April 30, 2019

22nd Century Group Facility Completes FDA Inspection

22nd Century Group announced it completed an inspection from the FDA of its manufacturing facility in North Carolina.
April 30, 2019

Xencor Shares Update on Phase 1 Study

Xencor announced the FDA lifted a partial clinical hold placed on its Phase 1 study of XmAb14045.
April 9, 2019

Myriad Genetics Submits First Module of Premarket Approval Application to FDA for myChoice® HRD CDx Test

Myriad Genetics (NASDAQ:MYGN) has announced it has submitted the first module of its premarket approval (PMA) application to the US...
April 5, 2019

Gilead Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Once-Daily Descovy

Gilead Sciences (NASDAQ:GILD) has announced it has submitted a supplemental new drug application (NDA) to the US Food and Drug...
April 4, 2019

Teligent Receives FDA Approval of Fluocinonide Cream USP, 0.1 Percent

Teligent (NASDAQ:TLGT) has announced it has received approval for its abbreviated new drug application from the US Food and Drug...