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10 August 2016 | By Niamh Louise Marriott, Digital Content Producer
Bonesupport’s Fortify study will evaluate the safety and efficacy of Cerament G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centres globally, with the aim of having at least 50% of the study data coming from…
29 July 2016 | By Mandy Parrett, Editorial Assistant
Shire Plc has announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
28 July 2016 | By Niamh Louise Marriott, Digital Content Producer
To find out more about Hepititis C, European Pharmaceutical Review spoke with Raquel Peck, CEO of the World Hepatitis Alliance and discovered exactly what it is being done to combat this widespread global health issue...
27 July 2016 | By Niamh Louise Marriott, Digital Content Producer
US FDA has approved Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of chronic genotype 1 (GT1) hepatitis C...
25 July 2016 | By Niamh Louise Marriott, Digital Content Producer
Morphochem announced today that the U.S. FDA has designated Morphochem’s intravenous antibacterial product as a Qualified Infectious Disease Product...
20 July 2016 | By Victoria White, Digital Content Producer
The US Food and Drug Administration (FDA) has approved an expanded label for Namzaric.
14 July 2016 | By Victoria White, Digital Content Producer
The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product...
14 July 2016 | By Victoria White, Digital Content Producer
If approved, chewable mebendazole will provide a treatment and prevention alternative for adults and children with soil-transmitted helminthiasis...
13 July 2016 | By Victoria White, Digital Content Producer
Prevnar 13 is now approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by S. pneumoniae...
12 July 2016 | By Victoria White, Digital Content Producer
With this approval, Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition...
11 July 2016 | By Victoria White, Digital Content Producer
The FDA has approved Genentech’s Xolair (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age...
1 July 2016 | By Victoria White, Digital Content Producer
The US Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy Designation for ibrutinib (Imbruvica) as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
1 July 2016 | By Victoria White, Digital Content Producer
Adalimumab is now the only FDA-approved non-corticosteroid therapy available for adults with non‑infectious intermediate, posterior and panuveitis...
29 June 2016 | By Victoria White, Digital Content Producer
Epclusa is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection...
28 June 2016 | By Victoria White, Digital Content Producer
If approved by the EMA and FDA for both indications, Ocrevus would be the first and only treatment for both forms of multiple sclerosis...
