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- PMLiVE

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- PMLiVE

Otsuka files new TB candidate in Japan as shortages worsen

Delamanid shows promise in multi-drug resistant TB but supplies of rifampin are low

- PMLiVE

FDA delays GlaxoSmithKline’s pandemic flu vaccine

More time needed due to "administrative" issue

FDA says final mobile app guidance just weeks away

And tells Congress only a fraction of mobile apps will need regulating

- PMLiVE

Takeda files lymphoma drug brentuximab vedotin in Japan

Seeks approval for antibody-drug conjugate for two forms of the blood cancer

- PMLiVE

Merck & Co’s sugammadex delayed in US

FDA says it needs more time to review application

- PMLiVE

FDA investigates pancreas risk of diabetes drugs

Products from Merck & Co, BMS, AZ, Novo Nordisk, Boehringer, Amylin and Takeda all involved

Novartis building

FDA deems Novartis lung cancer drug a “breakthrough therapy”

LDK378 will have accelerated passage through development

- PMLiVE

Vanda withdraws EU application for schizophrenia drug

CHMP had previously refused to back the approval of Fanaptum

- PMLiVE

FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

FDA smartphone regulation could stifle innovation

US House Republicans issue warning on guidance and call for more information

- PMLiVE

Novartis provides multimedia support to Rare Diseases Day

Collaborates with Eurordis on multimedia education campaign

- PMLiVE

Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

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