Pharmafile Logo

US Congress

- PMLiVE

FDA knocks back J&J and Bayer’s Xarelto in ACS

Follows unanimous negative committee vote

- PMLiVE

FDA knocks back Durect’s painkiller

Regulator wants more safety information for Posidur

- PMLiVE

FDA clears J&J’s Imbruvica for leukaemia

Adds to cancer drug's lymphoma indication

- PMLiVE

FDA to review safety of AZ’s saxagliptin

Diabetes drug linked to heart failure

- PMLiVE

FDA deems GSK anaemia drug a ‘breakthrough’

US regulator will accelerate review of Promacta

- PMLiVE

FDA approves sleep disorder drug for blind people

Vanda Pharmaceuticals wins backing for Hetlioz to improve a person’s body clock

- PMLiVE

FDA panel backs Merck’s vorapaxar

On course for US approval to reduce vascular events in certain patients

- PMLiVE

FDA panel backs Chelsea’s Northera for rare disease

Committee votes in favour of treatment for low blood pressure

- PMLiVE

Another Ranbaxy plant falls foul of FDA

Indian company violates Good Manufacturing Practice

FDA releases draft social media guidance

Covers 'interactive promotional media', such as Facebook, Twitter and blogs

- PMLiVE

Merck shares jump on melanoma drug filing

MK-3475 could be approved by end of 2014

Daiichi Sankyo logo

Daiichi files new anticoagulant edoxaban in US and EU

Seeks approvals in atrial fibrillation and venous thromboembolism

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links