List view / Grid view
11 January 2017 | By Niamh Marriott, Digital Editor
F901318 is the first member of a novel class of systemic antifungal agents targeting life threatening mould infections and acting through a target...
13 December 2016 | By Niamh Louise Marriott, Digital Editor
The European Medicines Agency (EMA) has accepted for review the marketing authorisation application for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
5 December 2016 | By Niamh Louise Marriott, Digital Editor
Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development...
18 November 2016 | By Niamh Louise Marriott, Digital Content Producer
The FDA granted priority review to the PKC412 (midostaurin) new drug application as treatment for acute myeloid leukaemia...
18 November 2016 | By Niamh Louise Marriott, Digital Content Producer
This conditional marketing authorisation is based on data from the Phase 2 portion of the pivotal JGDG trial and followed a positive recommendation from...
10 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Mabion signed a long-term development and commercialisation agreement with Mylan Ireland a wholly owned subsidiary of Mylan N.V.
7 November 2016 | By Niamh Louise Marriott, Digital Content Producer
The US Food and Drug Administration (FDA) accepted Novartis’ new drug application (NDA) for filing and granted priority review for LEE011 (ribociclib)...
4 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Studies showed that Nyxoid is bioequivalent to injectable naloxone as a first line treatment for opioid overdose, with an intranasal 1.8 mg dose...
20 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Calciphylaxis is a serious and rare condition characterised by vascular calcification and thrombosis leading to necrosis of the skin and fatty tissue...
19 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Gene therapy program ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA), a rare autosomal recessive disease...
10 October 2016 | By Niamh Louise Marriott, Digital Content Producer
An immunotherapy drug has been hailed as a ‘game changer’ after being found to greatly improve survival for patients with relapsed head and neck cancer...
7 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The VTS-270 clinical program is aimed at treating the neurological disease that is the primary cause of child mortality with Niemann-Pick Type C1 disease...
25 August 2016 | By Niamh Louise Marriott, Digital Content Producer
Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA...
5 August 2016 | By Bellicum Pharmaceuticals
Bellicum Pharmaceuticals, a clinical stage biopharmaceutical company, has been granted orphan drug designations for both its T-cell therapy product candidate BPX-501 for treatment in hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid...
25 July 2016 | By Niamh Louise Marriott, Digital Content Producer
Ipsen announced that CHMP & EMA have provided a positive opinion for Cabometyx for the treatment of advanced renal cell carcinoma (RCC) in adults...
