Bayer’s Adempas Overcomes FDA Dosing Concerns To Win Approval
This article was originally published in The Pink Sheet Daily
Riociguat becomes the first therapy indicated for chronic thromboembolic pulmonary hypertension in the U.S. Labeling includes Bayer’s recommended starting and maximum doses but provides the option for a lower starting dose in patients who may not tolerate the hypotensive effects, a concern for agency reviewers.
You may also be interested in...
Spun out from Ironwood with a $175m financing, Cyclerion added Bayer and Shire veteran Andreas Busch to its management team as Chief Innovation Officer as it awaits a trio of Phase II data readouts coming this year for its sGC stimulators.
'Limited activities related to user fee funded programs' will continue if Congress does not pass a short-term funding measure by Oct. 1.
FDA cleared the single pill combining conjugated estrogens with bazedoxifene, a novel selective estrogen receptor modulator, for two indications but issued a “complete response” letter for use in vulvar and vaginal atrophy.