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June 28, 2012
Japan's Shionogi says that the US Food and Drug Administration has agreed to review ospemifene for the treatment of vulvar and vaginal atrophy (VVA) due to menopause
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May 24, 2012
Takeda says that regulators in Europe have agreed to review its type 2 diabetes therapy alogliptin, a month after receiving a knockback from the FDA
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February 17, 2012
GlaxoSmithKline has withdrawn one submission to expand the label on Tyverb in Europe, after the regulator expressed concerns about the data, but has filed fresh regulatory applications on both sides of the Atlantic for the breast cancer drug
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February 07, 2012
Merck & Co has unveiled plans to submit its new insomnia drug suvorexant for regulatory approval in the USA this year.
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January 06, 2012
Shire's plans to sell its blockbuster attention deficit hyperactivity disorder drug Vyvanse in Europe has advanced with the news that the drug, to be called Venvanse, has been accepted for review
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January 03, 2012
Bayer and Johnson & Johnson are looking to get a third approval in the USA for the oral anticoagulant Xarelto
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December 02, 2011
GlaxoSmithKline is hoping it will be third time lucky and is again trying to get approval in the USA for its meningitis vaccine MenHibrix
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November 10, 2010
Merck & Co has decided to pull a submission for its new asthma treatment Zenhale in Europe, after the regulator required more data
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