US FDA Pushes Back GSK’s Momelotinib Decision

Ruling Now Expected By 16 September

GSK remains confident of approval despite the delay, with hopes of blockbuster sales for its myelofibrosis candidate.

new gsk logo and hq
• Source: GSK

GSK will have to wait three months longer for the US Food and Drug Administration to make a ruling on its myelofibrosis candidate momelotinib, with the agency pushing back its decision date to 16 September.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Blood and Clotting

More from Therapy Areas

GSK Chief Optimistic About BD Despite Volatile Environment

 
• By 

Emma Walmsley tells Scrip that the "biotech market is under a certain degree of pressure," so reasonably priced deals are available.

In Brief: AbbVie’s Rinvoq Secures US Approval For Giant Cell Arteritis

 

JAK inhibitor gains ninth indication in US after a strong performance in the first quarter.

CSPC’s Global-First Monospecific ADC Promising In Advanced NSCLC

 
• By 

CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.