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