GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting ...

GSK shares fell more than 6% on Friday to the bottom of Britain's blue-chip index after a U.S. FDA advisory panel recommended ...

Recent developments in the health sector highlight diverse changes from drug pricing initiatives by Bristol Myers and Pfizer ...

GSK plc (NYSE:GSK) has strengthened its market outlook following major regulatory milestones. The U.S. FDA’s recent approval of Nucala for chronic obstructive pulmonary disease (COPD) and a ...

GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment ...

As a result of the regulatory updates in both the US and EU, GSK now expects global sales of Avandia products to be in a range of approximately £100m - £150m in the second half of 2010 and with ...

(RTTNews) - The U.S. Food and Drug Administration has accepted for review a Biologics License Application or BLA for GSK plc.'s (GSK, GSK.L) 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate ...

GSK's multiple myeloma drug Blenrep nearly halved the risk of disease progression or death compared to standard-of-care treatments for the incurable blood cancer, according to data from a late ...

This is the third regulatory designation for GSK’227, following the European Medicines Agency’s decision to grant Priority Medicines, PRIME, designation and the FDA’s decision to grant ...

The filing gives GSK an impressive slate of 6 new drugs up for regulatory review and the chance to boast about the productivity of its restructured R&D operation.