Iterum Therapeutics plc , announced its initiation of the first of three Phase III clinical trials. In this trial, known...

Vertex Pharmaceuticals Incorporated announced the FDA approved Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12...

United Therapeutics Corporation announced that preliminary analysis indicates that the FREEDOM-EV clinical study of Orenitram (treprostinil) extended-release tablets in patients...

ViiV Healthcare announced positive headline results from its global, phase III ATLAS study of a long-acting, injectable two-drug regimen (2DR)...

Ironshore Pharmaceuticals & Development, Inc. a wholly owned subsidiary of Highland Therapeutics Inc. has announced that the FDA has approved...

The National Institute for Health and Care Excellence (NICE) has formally invited Biogen to submit Spinraza (nusinersen) for Single Technology...

Grifols announced that the FDA approved the Procleix Zika Virus assay for the detection of the virus in individual or...

Motif Bio plc has announced that the FDA has accepted for filing the New Drug Application (NDA) for iclaprim, a...

Ligand Pharmaceuticals Incorporated and Vernalis plc announce that Ligand has declared its firm intention to acquire the entire issued and...

Regeneron Pharmaceuticals, Inc.y announced that due to ongoing labeling discussions the FDA has issued a complete response letter (CRL) regarding...