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Onglyza

- 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

National Institute for Health and Care Excellence NICE logo

Janssen launches diabetes drug Invokana in UK

Launch coincides with draft NICE recommendation for the SGLT2 inhibitor

- PMLiVE

Teva’s Symbicort generic backed for EU approval

AstraZeneca braces for competition to COPD drug

- PMLiVE

Janssen Invokana combination recommended for European approval

Drug adds metformin to the firm's new SGLT2 inhibitor

- PMLiVE

Interview: Phil Southerland, Team Novo Nordisk

The man behind the world's first all-diabetes cycling team

- 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

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