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- PMLiVE

healthcare reforms

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Lilly/Boehringer’s empagliflozin faces US approval delay

FDA cites manufacturing issues with the new diabetes drug

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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

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GSK files Promacta for anaemia indication in US

FDA will review drug under ‘breakthrough’ designation

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Gliptins don’t cause pancreatic cancer say FDA and EMA

Regulators back safety of diabetes medicine class

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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

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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

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FDA approves Chelsea’s rare blood pressure drug

US biopharma company gets green light in US for Northera

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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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