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- PMLiVE

cemiplimab

- 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

Lilly’s ramucirumab boosts survival in lung cancer

Late-stage trial backs regulatory prospects

- 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

Novartis building

Novartis skin cancer drug clears pivotal trial

Sonidegib achieves significant response in basal cell carcinoma patients

- 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

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