The FDA will review the expansion of Anktiva plus BCG to patients with papillary-only bladder cancer, with a final decision expected by Jan.6, 2027. ・The acceptance reversed last year’s FDA refusal-to ...
The FDA is reviewing an sBLA for nogapendekin alfa inbakicept-pmln plus BCG to treat BCG-unresponsive NMIBC with papillary disease without CIS.
CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced treatment with ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus ...
Anktiva plus BCG aims to treat BCG-unresponsive NMIBC with papillary disease, potentially reducing radical cystectomy need. The treatment showed high rates of surgery avoidance and disease-free ...
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug ...
The MarketWatch News Department was not involved in the creation of this content. -- Following discussions with the U.S. FDA, the Agency recommended that the Company submit additional information for ...
The TAR-200 system offering sustained intravesical gemcitabine release shows favorable response and tolerability in both the CIS and papillary-only subgroups with BCG-unresponsive high-risk NMIBC. TAR ...
Oral presentation provides update from QUILT-3.032 on durable complete responses to ANKTIVA® plus BCG in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) with or ...
Shares of ImmunityBio IBRX were up 3% in after-market trading yesterday after the company announced that the FDA accepted its ...
Ferring Pharmaceuticals today announced a new real-world case series demonstrating that re-induction with ADSTILADRIN ® (nadofaragene firadenovec-vncg) resulted in complete responses (CR) in ...
ImmunityBio's stock is moving higher after the FDA announced it would review a possible label expansion for the company's ...
CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA ...