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- PMLiVE

FDA lowers recommended dose for sleeping pills

Says insomnia drugs like Ambien could impair ability to drive in morning

- PMLiVE

FDA releases guidance on how to prevent abuse of opioid painkillers

Explains to companies best ways to make tamper-resistant drugs

- PMLiVE

FDA clears six new drugs in time for the new year

Brings 2012 tally to 39 – the highest for more than 15 years

- PMLiVE

Year-end FDA approvals for Novartis, GSK drugs

Agency gives go-ahead to Cushing’s disease treatment Signifor and raxibacumab for inhalational anthrax

- PMLiVE

Early FDA approval for Ariad’s leukaemia drug Iclusig

Available in US three months ahead of schedule

- PMLiVE

FDA approves Exelixis’ Cometriq for rare thyroid cancer

Genomics-based discovery company also submits the drug to EU regulators

- PMLiVE

Ranbaxy recalls generic Lipitor in US

Several batches withdrawn after some products found to contain small particles of glass

US HHS secretary Sebelius subpoenaed over health reform promotion

House Republicans demand investigation into Affordable Care Act PR

- PMLiVE

Shire promotes Dr Jeff Jonas to lead regenerative medicines business

His former role leading specialty pharma R&D will be filled by Arnaud Partiot

- PMLiVE

Obama victory ensures US healthcare reforms will continue

Republican hopeful Mitt Romney unable to act on plan to repeal Affordable Care Act

- PMLiVE

FDA approves Teva’s leukaemia drug Synribo

Accelerated approval means early competition for Pfizer’s Bosulif

- PMLiVE

Shire picks Bayer’s Flemming Ornskov as new head

He will succeed Angus Russell who is retiring next year

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