The company has resubmitted its Biologics License Application for Ryoncil in the U.S. and is preparing for its commercial launch, while also advancing trials for other promising therapies. Financially ...

Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 2024, the Company expanded our product portfolio and possible disease indications that may be treated with our immunotherapeutic ...

Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...

Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.

The approval marks the first time gene therapy will be available to treat patients with aromatic I-amino acid decarboxylase ...

Participants were broken into two cohorts. The first cohort received one of three doses of PCRX-201. The second cohort received concurrent pretreatment with an intraarticular corticosteroid ...

Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA ...

As described in previous updates, we have been working closely with FDA regarding the anticipated resubmission of our Biologics License Application, or BLA for narsoplimab in hematopoietic stem cell ...

following the approval of ATSN-101’s Biologics License Application (BLA), the company will retain all rights, title, and ...

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for prademagene zamikeracel for the treatment of recessive dystrophic epidermolysis ...

Zai Lab and argenx have announced receipt of approval from the National Medical Products Administration (NMPA) of China for ...