Up to $100 million in additional loan proceeds provide additional financial flexibility to advance detalimogene development ...
FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates to the BLA in ...
Mesoblast says FDA feedback supports filing plans for its cell therapy to treat chronic back pain, showing reduced pain and ...
NovaBridge as we executed a new business strategy and built a truly global platform. This, combined with compelling Phase 1b ...
ImmunityBio, Inc. is upgraded to Buy reflecting improving Anktiva data & potential label expansions in NMIBC and NSCLC. Read ...
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the Saudi Food and Drug ...
The FDA has accepted the supplemental Biologics License Application (BLA) for ropeginterferon alfa-2b-njft (Besremi), a ...
As biotechs faced investors at the J.P. Morgan Healthcare Conference this week, they emphasized agreement with the FDA on ...
Japan's Ministry of Health, Labour and Welfare (MHLW) grants MCO-010 Sakigake (Pioneering Regenerative Medical Product) and Orphan Drug designations, enabling an accelerated regulatory pathway for ...
Despite a significant 48.8% objective response rate and breakthrough therapy status, this regulatory shift reverses years of ...
OS Therapies releases trial data supporting FDA approval, U.K. and U.S. timelines, and potential eligibility for a valuable ...
ImmunityBio stock rose 19.8% after FDA meeting on ANKTIVA bladder cancer treatment. Company to submit additional data within ...
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