9,224 Results

FDA approves Kalydeco to treat cystic fibrosis in children aged 12 to <24 months.- Vertex Pharma.

 Added 16 hours ago

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

Phase III FREEDOM-EV study shows Orenitram delays disease progression in pulmonary arterial hypertension patients- United Therapeutics

 Added ago

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

First Phase III trial of sulopenem + probenecid versus ciprofloxacin to treat women with UTI infections.- Iterum Therapeutics.

 Added ago

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

Phase III ATLAS study success for two-drug regimen ,namely cabotegravir and rilpivirine, for the treatment of HIV compared with continuing a three-drug oral regimen. ViiV HealthCare + Janssen Therapeutics.

 Added 16 hours ago

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

FDA approves Jornay PM to treat ADHD symptoms.- Ironshore Pharma & Development Inc.

 Added 16 hours ago

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

NICE requests Biogen to submit Spinraza for single technology appraisal as a treatment for spinal muscular atrophy.

 Added 1 day ago

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

FDA approves Procleix Zika Virus assay for detection of Zika virus.- Grifols.

 Added 1 day ago

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

FDA accepts NDA for iclaprim to treat ABSSSI.- Motif Bio plc.

 Added 1 day ago

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

Vernalis plc is to be acquired by Ligand Pharma

 Added 2 days ago

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

Delay in US for sBLA for Eylea for patients with wet age-related macular degeneration (wet AMD) 12 week dosing schedule.- Regeneron + Bayer

 Added 2 days ago

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

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