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

Horizon Pharma

- PMLiVE

Lilly/Boehringer’s empagliflozin faces US approval delay

FDA cites manufacturing issues with the new diabetes drug

- PMLiVE

Translational pharmacology: the key to ensuring safe and effective dosing

Designing pharmacokinetic and toxicokinetic studies during preclinical and early phase 1 trials will maximise a candidate’s chance of safety and efficacy success

- PMLiVE

GSK files Promacta for anaemia indication in US

FDA will review drug under ‘breakthrough’ designation

- PMLiVE

Gliptins don’t cause pancreatic cancer say FDA and EMA

Regulators back safety of diabetes medicine class

- PMLiVE

AZ gets limited approval for metreleptin in US

First FDA-backed treatment for rare disease lipodystrophy

Bristol-Myers Squibb (BMS) building

BMS’ oral hepatitis C regimen gets breakthrough status

Combines daclatasvir and asunepravir

- PMLiVE

FDA expands efforts to test quality of generics

Monitoring programme to ensure drug copies are equivalent to branded medicines

- PMLiVE

EMA and FDA create pharmacovigilance ‘cluster’

Monthly meetings to discuss key issues in medicines safety

- PMLiVE

FDA mulls use of side effect voiceover in TV advertising

Agency considers updating how drug risks are communicated

- PMLiVE

FDA approves Chelsea’s rare blood pressure drug

US biopharma company gets green light in US for Northera

- 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

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links