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- PMLiVE

Non-24

- PMLiVE

New FDA guidance for advertising

Clarifies circumstances when drug names need to be mentioned

- PMLiVE

Rare disease strategy for the UK launched

Aims to improve understanding and boost research

- PMLiVE

FDA turns down Forest/Gedeon Richter’s antipsychotic

US regulator wants more information for cariprazine

- PMLiVE

AZ drug for opioid constipation starts FDA review

Naloxegol on course to compete with Takeda’s Amitiza

- PMLiVE

Teva withdraws US filing for cancer biologic

FDA requests more data for balugrastim

- PMLiVE

FDA panel backs sleep pattern drug for blind

Vanda’s Hetlioz intended to improve circadian rhythms in people who cannot see

- PMLiVE

FDA clears J&J’s breakthrough lymphoma therapy

Imbruvica approved to treat mantle cell lymphoma

- PMLiVE

Sarepta slumps as FDA questions muscular dystrophy drug

US regulator casts doubt on biomarker for eteplirsen

Shire Basingstoke

Shire snaps up Viropharma to build $2bn rare disease unit

Gains access to Cinryze in expensive but 'strategically sound' deal

- PMLiVE

EMA to review safety of Ariad’s Iclusig

Product information will be updated to warn of blood clot risk

Shire Basingstoke

Shire mulls UK job cuts

Enters “employee consultation process” for research site in Basingstoke

- PMLiVE

UCB files Vimpat for expanded epilepsy use

Submits monotherapy application to FDA


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