Shots: The FDA’s clinical hold is based on interim safety findings from a pre-clinical study which showed that 6/7 animals treated with BMN 307 (2e14 Vg/kg) had tumors on liver […]readmore
Tags : reports
Shots: The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after […]readmore
Shots: The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to sev. active UC who had […]readmore
Shots: The company has completed the enrollment in the P-IIB HOPE4MCI trial evaluating the efficacy of AGB101 vs PBO in 164 patients to treat amnestic mild cognitive impairment due to […]readmore
Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based […]readmore
Shots: The company reported new post hoc data from the P- III ASCLEPIOS trials assessing Kesimpta (ofatumumab) vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with RMS The […]readmore
Shots: The P-II KINETIC study involves assessing the efficacy, safety, and tolerability of SAGE-324 (60mg, qd) vs PBO in 69 patients in a ratio (1:1) aged 18-80yrs. with essential tremor […]readmore
Shots: MD Anderson will sponsor and lead P-I/II study to assess DS-1594 as monothx. and in combination regimens for patients with r/r AML and ALL The 1EPs of the P-I […]readmore
Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected […]readmore
Shots: The company has completed the enrollment in the first cohort of P- I/II trial involves assessing AMT-130 in 10 patients, out of which six patients received treatment with AMT-130 […]readmore