The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.

Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.

Guest speaker and lawyer Kevin Duan joins Brian Yang and Dexter Yan to discuss the planned US BIOSECURE Act, the US approval of BeiGene's anti-PD-1 drug and the latest antibody-drug conjugates in development at Chinese pharma firms.

Agency has notably rejected some NDAs that relied solely on Chinese data, but a positive advisory committee for Geron’s proposed anemia treatment imetelstat and approval for BeiGene’s anti-PD-1 antibody Tevimbra suggest that using a lot of foreign data could be OK.