US FDA accepts Flutiform NDA

SkyePharma is one step closer to US approval for its lead development product, the combination asthma therapy Flutiform (fluticasone propionate plus formoterol fumarate).

SkyePharma is one step closer to US approval for its lead development product, the combination asthma therapy Flutiform (fluticasone propionate plus formoterol fumarate).

The product has been accepted for filing by the FDA for the treatment of persistent asthma in patients aged 12 years and older, triggering a $2 million milestone payment from...

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 Respiratory

More from Therapy Areas

Ascentage Broadens Horizons As Pipeline Shows Renewed Promise

 
• By 

Ascentage will share at ASCO new clinical data on its Bcl-2 inhibitor lisaftoclax, part of the Chinese firm's novel pipeline, on which its CEO shared with Scrip plans and strategy, along with some views on the use of RWD in China.

ASCO Preview: Major Solid Tumor Readouts Include AstraZeneca/Daiichi, Gilead ADCs

 

Data from several closely watched solid tumor drug trials – some considered practice-changing – are scheduled for presentation at the meeting, including for AstraZeneca and Daiichi’s Enhertu.

Gilead Ready To Go After Hepatitis D Again

 
• By 

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.