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- PMLiVE

pre-exposure prophylaxis (PrEP)

- PMLiVE

Otsuka and Lundbeck file Abilify follow-up in the US

Brexpiprazole to be reviewed for use in schizophrenia and major depressive disorder

The seven letter debate that is Sovaldi

Reimbursement of high cost hepatitis C drugs raise difficult issues

- PMLiVE

Sun Pharma recalls antidepressant in US

Withdraws more than 40,000 bottles of venlafaxine hydrochloride

- PMLiVE

FDA sets out framework for rare childhood diseases

Wants to encourage more trial use of biomarkers and speedier approval timelines

- PMLiVE

FDA to review Sanofi’s Lantus successor

Decision on company’s next generation insulin Toujeo expected early next year

- PMLiVE

Amgen and Boehringer drugs win FDA breakthrough status

Leukaemia drug and Pradaxa antidote will benefit from accelerated regulatory processes

- PMLiVE

Third time lucky as MannKind’s inhaled insulin is approved

US FDA backs new diabetes treatment Afrezza

- PMLiVE

AZ needs more data on olaparib, says FDA panel

Agency advisers demands more safety information on ovarian cancer drug

- PMLiVE

FDA adds blood clot warning to testosterone products

Warns of risk of developing deep vein thrombosis and pulmonary embolism

FDA shares new #socialmedia guidance

Latest recommendations cover Twitter, paid search links and correcting misinformation

Gilead Sciences

Sovaldi stumbles as NICE assesses hep C drug’s price

Gilead must provide much more cost-effectiveness information

- PMLiVE

FDA approves Biogen Idec’s haemophilia drug

Eloctate now available to help control and prevent bleeding episodes

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