Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

Cepheid

- PMLiVE

US and Indian regulators forge closer ties

FDA signs new agreement with India's Ministry of Health and Family Welfare

- PMLiVE

FDA backs BioMarin drug for rare enzyme disorder

Vimizim is first drug approved in US under rare paediatric disease priority review

- 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

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links