Tag:
Flutiform
Latest Headlines
Latest Headlines
SkyePharma's inhaler takes step toward EMA approval
After years of delays and rejections, SkyePharma is finally getting some good news on Flutiform.
New year brings new delay for SkyePharma's Flutiform asthma inhaler
It's likely that SkyePharma isn't having a "Happy New Year" just yet. That's because the British drug delivery company now stands to face an additional delay of between 6 and 9 months in the approval
Abbott bows out of Flutiform pact
Following the FDA's decision in June to require more clinical trials of SkyePharma's asthma drug Flutiform, partner Abbott has returned U.S. marketing rights to the British drugmaker. Under an
SkyePharma shares blitzed after FDA spurns Flutiform app
SkyePharma's long-troubled attempt to gain FDA approval for the asthma drug Flutiform officially hit a brick wall today, with the agency demanding what the developer termed significant new clinical
FDA rejects SkyePharma's NDA for Flutiform
The U.K.'s SkyePharma says the FDA has officially rebuffed its NDA for the asthma drug Flutiform, its lead drug prospect, spelling out "substantive" issues that need to be resolved ahead of an
In setback, FDA demands new work on SkyePharma's Flutiform
The FDA is throwing a hurdle in the way of SkyePharma's experimental asthma therapy Flutiform. As the U.K. developer had feared, the agency is demanding new clinical work on dosing before it will
SkyePharma faces regulatory delay for lead drug
Shares of SkyePharma were sliding this morning after the UK developer told investors that the FDA would probably come back with a request for more data on its lead drug Flutiform, adding to the time
SkyePharma files for Flutiform approval
In what CEO Ken Cunningham called a "major milestone," the UK's SkyePharma filed for FDA approval of its asthma drug Flutiform. Flutiform is SkyePharma's biggest drug prospect, with estimated annual
