Shots: The company has reported the voluntary withdraw of balstilimab’s BLA in patients with cervical cancer, following the US FDA’s recommendation & the decision follows the full approval of pembrolizumab […]readmore
Tags : Withdrawal
Shots: The withdrawal follows the recent discussion with the US FDA regarding the palovarotene’s NDA review that initiated in May’21 The additional analysis will be required to progress and complete […]readmore
Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. […]readmore
Shots: The withdrawal follows the failure of P-III ANNOUNCE study assessing Lartruvo (olaratumab) + doxorubicin followed by Lartruvo as monothx vs doxorubicin + PBO followed by PBO in patients with […]readmore