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- PMLiVE

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- PMLiVE

FDA urged to give biosimilar medicines distinct scientific names

Alliance for Safe Biologic Medicines highlights safety concerns if different products have same name

- PMLiVE

FDA clears Sanofi’s oral MS drug Aubagio

Will compete with Novartis’ Gilenya

- PMLiVE

J&J responds to FDA concerns over Xarelto in ACS

Responds to regulator about missing clinical trial data

FDA sued for approving high dose of Eisai’s Alzheimer’s drug Aricept

Consumer rights group Public Citizen claims the high-strength dose is unsafe

Novartis building

FDA panel backs Novartis’ updated cystic fibrosis drug

New version of inhaled tobramycin therapy is simpler to use

- PMLiVE

US drug approval numbers fall despite pharma investing more in R&D

Stricter FDA policies are partly to blame for the decline says GBI Research

Pfizer gets US approval for leukaemia drug Bosulif

FDA grants the tyrosine kinase inhibitor a licence to treat chronic myelogenous leukaemia

Astellas wins US approval for prostate cancer drug Xtandi

Pharma company and its partner Medivation gain FDA licence for type of late-stage prostate cancer

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