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- PMLiVE

tolvaptan

Otsuka’s Samsca heads clutch of Japanese approvals

Astellas' Xtandi, AstraZeneca's Forxiga and Takeda's Zacras also given the green light

- PMLiVE

Pfizer’s meningitis vaccine ‘a breakthrough’

FDA to speed up review process for bivalent rLP2086

- PMLiVE

Celgene gets FDA OK for first oral psoriatic arthritis drug

Otezla wins US approval to treat the auto-immune disease

- PMLiVE

Abilify Maintena launches in Europe

Schizophrenia treatment is a key product to help Lundbeck replace lost Cipralex sales

- PMLiVE

FDA approves migraine headband

STX-Med’s electronic Cefaly device offers drug-free treatment option

- PMLiVE

FDA scrutiny of alirocumab hits Regeneron and Sanofi

Regulator to assess neurocognitive effects of cholesterol drug

- 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

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