List view / Grid view
8 June 2015 | By Victoria White
A Phase II clinical trial testing the ability of the generic vaccine BCG to reverse advanced type 1 diabetes has received approval from the FDA...
3 June 2015 | By Victoria White
The FDA has accepted for review the sBLA for Merck’s anti-PD-1 therapy, Keytruda, for the treatment of patients with advanced non-small cell lung cancer...
2 June 2015 | By Victoria White
The FDA has accepted the supplemental Biologics License Application for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma...
1 June 2015 | By Victoria White
The US Food and Drug Administration (FDA) has approved Pfizer’s RAPAMUNE (sirolimus) in the US for the treatment of lymphangioleiomyomatosis (LAM)...
22 May 2015 | By Victoria White
Tris Pharma has announced that the FDA has accepted for review its New Drug Application for Dyanavel XR, an Extended-Release Oral Suspension...
21 May 2015 | By Victoria White
The FDA has granted Orphan Drug Designation to Alnylam’s revusiran for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis)...
20 May 2015 | By Victoria White
The FDA have approved Janssen’s New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza...
11 May 2015 | By Victoria White
The FDA has approved Avelox in the US to treat patients with plague, including pneumonic plague and septicemic plague...
6 May 2015 | By Victoria White
NDA Group's new Infographic looks at drug approvals in 2014 and highlights the fact that nearly 40% of approved products came from non top pharma companies...
5 May 2015 | By Victoria White
Vernalis and Tris Pharma have announced that the FDA has approved the New Drug Application for Tuzistra XR extended-release oral suspension...
27 April 2015 | By Victoria White
The FDA has approved Cyramza in combination with FOLFIRI chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC)...
23 April 2015 | By Victoria White
A surgical team has completed the world’s first clinical procedure using cold plasma for the selective killing of cancerous tissue...
15 April 2015 | By Victoria White
The U.S. Food and Drug Administration (FDA) has agreed to the proposed Phase 3 clinical development programme for Motif’s lead product candidate, iclaprim...
13 April 2015 | By Victoria White
The FDA has modified the partial clinical hold on the IND for TKM-Ebola to permit repeat dosing of healthy volunteers at a dose of 0.24 mg/kg/day...
13 April 2015 | By Victoria White
Shire has announced that the FDA has accepted for filing the New Drug Application (NDA) for Lifitegrast and granted a Priority Review designation...
