Phase III
The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.
FDA rejected OPKO’s once-weekly human growth hormone, somatrogon, which it co-developed with Pfizer for the treatment of growth hormone deficiency (GHD) in pediatric patients.
Last week was a relatively quiet week for clinical trial news, particularly around COVID-19. Here’s a look.
The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
January has been a largely quiet month for PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. There were two dates for the entire month, and one of those has been moved back to April. Here’s a look.
The data is coming in right away for Alnylam in one of its primary indications, transthyretin-mediated (ATTR) amyloidosis.
As part of a company-wide workforce reduction, it will cut its employee headcount by at least 25% by the end of the year, and 50% of its senior management team are leaving the company.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
The companies announced that Dupixent was the first biologic to significantly reduce itch and skin lesions in patients with Prurigo Nodularis in the Phase III trial.
AstraZeneca has been struggling to find an effective use for its anti-CTLA-4 antibody tremelimumab. It may have finally found it.
PRESS RELEASES