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- PMLiVE

Janet Woodcock

Sanofi reception

FDA to review Sanofi’s lixisenatide for diabetes

Follows drug's European approval under brand name Lyxumia earlier this month

- PMLiVE

Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

- PMLiVE

Genzyme’s Richard Moscicki joins FDA

Provides regulatory agency with more than 20 years of industry experience

- PMLiVE

FDA fast-tracks Bayer’s prostate cancer radiotherapy

Priority review for radium-223 dichloride, formerly called Alpharadin

- PMLiVE

Bayer submits oral PAH drug riociguat for approval

Set to challenge Actelion and Gilead

- PMLiVE

Celgene gets US green light for blockbuster candidate Pomalyst

FDA approval to treat multiple myeloma

- PMLiVE

FDA proffers guidance for new Alzheimer’s drugs

Encourages approach that tackles disease in its early stages

- PMLiVE

FDA says approval of generic Doxil will ease cancer drug shortage

Allows Sun Pharma to manufacture its own version of the medicine

FDA clears Hyperion’s Ravicti for urea cycle disorders

Plans to launch in US by end of April

- PMLiVE

FDA advisors back Boehringer’s COPD drug olodaterol

Committee votes 15 to 1 in favour despite cancer concerns

Sanofi reception

US approval for Sanofi’s Kynamro in genetic cholesterol disorder

Comes one month after drug was turned down in Europe due to safety concerns

- PMLiVE

Takeda gets FDA approval for alogliptin franchise in diabetes

Comprises Nesina, Oseni and Kazano

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