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

adverse events

- PMLiVE

Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

Search appears on FDA’s radar once again

Warning letter to Florida company puts new slant on regulator's digital focus

- PMLiVE

OncoAssist becomes latest app to be classified as a medical device

Cancer iPhone and iPad app offers clinical decision support tools

- PMLiVE

New UK guidance on data protection in pharmacovigilance

In a guest blog the ABPI's Esteban Herrero-Martinez sets out some key steps for pharma companies to consider

- PMLiVE

Bayer’s Diane 35 faces ban in France

Follows investigation into blood clot-related deaths

- PMLiVE

EMA starts contraceptive safety probe

Follows French investigation into Bayer’s Diane 35

Novartis building

Novartis withdraws application for Ruvise approval in EU

Had submitted imatinib mesylate for use in hypertension

- PMLiVE

EMA publishes marketing application guidance for pharma

Aims to clarify what to include in summaries of product characteristics

- PMLiVE

Pfizer gets CHMP backing for leukaemia drug bosutinib

Provides option for patients resistant to tyrosine kinase inhibitors

- PMLiVE

Santhera’s Raxone turned down for rare eye condition

EMA concerned about drug's ability to improve eyesight

- PMLiVE

EMA recommends suspension of Merck’s Tredaptive

Pharma company had already anticipated decision by withdrawing product worldwide

EMA launches eSubmission web tool

Will accept eCTD applications from January 15

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links