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The company said that prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these

The CHMP concluded that the benefits of Seasonique outweigh its risks clearing the way for the drug’s approval by local health authorities of the European Union (EU) Member

Investigator Peter Humphrey and his wife Yu Yingzeng were arrested by Chinese police in July 2013 following work they did for GSK. GSK hired Humphrey’s Chinese corporate investigations

"Hospira’s acquisition of the Orchid API facility will support supply continuity of key beta-lactam antibiotic products, improve our cost position and pave the way for future API development,"

Anoro is a once-daily combination treatment comprised of two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single

Dovobet® Ointment is a topical combination of active vitamin D3 calcipotriol and the corticosteroid betamethasone dipropionate. LEO Pharma K.K. filed an application for approval to the Ministry of

The acquisition includes one product marketed under an Abbreviated New Drug Application (ANDA) – Ursodiol tablet – and one approved ANDA that is not yet marketed – Lamotrigine

Alectinib’s approval was based on data from a Japanese Phase I/II clinical trial (AF-001JP) for people whose tumours were advanced, recurrent or could not be removed completely through

The approval is based on data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial. In