Neuvivo and the FDA have agreed on a regulatory pathway for NP001 (sodium chlorite) to treat ALS, with Phase 3 testing ...

Patient randomization is nearly complete in Medicinova’s Phase 2b/3 COMBAT-ALS trial testing MN-166 (ibudilast) for the ...

Apnimed has scored another phase 3 knockout. The Massachusetts biotech’s daily pill for obstructive sleep apnea reduced the ...

AIPAC-003 is a randomized, double-blind, placebo-controlled phase 3 trial testing efti plus paclitaxel in HER2-neg/low MBC pts, including an initial open-label dose optimization lead-in (DOL) ...

Separately, BMS plans to initiate another phase 3 trial next year for Opdualag in first-line nonsquamous NSCLC patients with PD-L1 expressions of at least 50%, Chief Medical Officer Samit Hirawat ...

Axsome did not address a regulatory filing timeline for Sunosi in the indication. CEO Herriot Tabuteau, M.D., said that the company plans to initiate a trial in pediatric patients this year ...