FDA committee recommends approval of Keytruda in high-risk NMIBC
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 in favour of approving Keytruda for the new indication. The anti-PD-1 therapy has already been approved in the US
Armada Acquisition has entered a definitive business combination agreement with Brains Bioceutical that values the latter at an implied pre-money equity value of about $750m.
In the study, participants taking AMX0035 had a statistically significant slowing of ALS disease progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) compared to placebo (p<0.05),
The two phase 3 trials for Jardiance called EMPERIAL-Reduced and EMPERIAL-Preserved were carried out in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. In
The study showed adding Tecentriq (atezolizumab) to Cotellic (cobimetinib) and Zelboraf (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and
TED is a rare, serious, progressive and vision-threatening autoimmune disease, and is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement that can