Latest Breaking News On - Therapy designation - Page 7 : comparemela.com

Why Is ImmunityBio Stock Trading Higher On Tuesday? - ImmunityBio (NASDAQ:IBRX)

FDA approves ImmunityBio's Anktiva plus Bacillus Calmette-Guérin for BCG-unresponsive non-muscle invasive bladder cancer. Anktiva shows promising complete response rates and duration exceeding 24 months.

Ziftomenib Granted Breakthrough Therapy Designation by FDA in R/R AML

The investigational drug ziftomenib is currently being evaluated for patients with relapsed/refractory NPM1-mutant acute myeloid leukemia.

FDA Approves ImmunityBio's Bladder Cancer Drug, Stock Rallies

Monday, the FDA approved ImmunityBio Inc’s (NASDAQ:IBRX) Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The drug is combined with the BCG vaccine, mainly used against tuberculosis and as a common treatment for some forms of bladder cancer. Last year in May, the FDA issued a complete response letter to Anktiva plus BCG treatment

BioXcel planning pivotal trial of BXCL501 for Alzheimer's agitation

FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations