GSK news

- Upfront and potential consideration of over $500 million

GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine.

GlaxoSmithKline (GSK) today announced that it has signed an agreement with the World Health Organization (WHO) to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to WHO for distribution to developing countries most in need.

GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010.

GlaxoSmithKline (GSK) today announced the results from the clinical trial assessing Pandemrix™, GSK’s adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ®.

Endorsement is first for vaccine for pneumococcal disease - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day

Endorsement is first for vaccine for pneumococcal disease - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day

Pivotal testing of RTS,S is on track for target enrollment of 16,000 children

Dr Dominique Limet, CEO of ViiV Healthcare, promises 'relentless pursuit' of new treatments

GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX) announced today that, on 30 October, they filed a New Drug Application with the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMEA), for retigabine, used as adjunctive therapy to treat adult epilepsy patients with partial-onset seizures