Pharmafile Logo

roxadustat

- PMLiVE

EASD 2013: Sanofi justifies decision to withdraw US filing for Lyxumia

Takes issue with FDA's narrow risk-benefit focus

FDA takes ‘tailored’ approach to mobile app regulation

Issues final guidance on smartphone and tablet computer technology

- PMLiVE

EMA backs drugs from Novo, Otsuka, AZ, Janssen, GSK

Nine new branded medicines recommended for use in Europe

- PMLiVE

Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

- PMLiVE

FDA to review AZ’s fish oil drug Epanova

Hypertriglyceridaemia treatment acquired as part of Omthera takeover

- PMLiVE

This month in 2010: How one woman helped prevent a health crisis in the US

The FDA's Frances Oldham Kelsey honoured for her work to prevent the use of thalidomide

- PMLiVE

Breakthrough status for GSK/ Genmab’s Arzerra

Speeds up FDA review for use in chronic lymphocytic leukaemia

- PMLiVE

FDA panel backs Perjeta in early breast cancer

Unanimous recommendation for use alongside Herceptin

- PMLiVE

AZ licenses Merck ovarian cancer drug

Pays $50m upfront for MK-1775

- PMLiVE

FDA guidance clears path for Advair generics

Offers simplified process for potential copies of GSK’s asthma and COPD drug

- PMLiVE

AZ sponsors heart attack risk app

GRACE 2.0 app aims to help HCPs decide on the most appropriate treatments

- PMLiVE

Celgene wins US pancreatic cancer indication for Abraxane

Adds to breast cancer and lung cancer indications

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links