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 ...

ANX005 in Guillain-Barré syndrome (GBS): First-in-kind monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain has the potential to be the ...

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

UK-based Adaptimmune will submit a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...

Reports Q3 revenue $0 vs. $0 last year. “With the acceptance of our Biologics License Application resubmission for pz-cel, we are ramping up our commercial readiness efforts, especially with respect ...

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 ...

Members of the Alcoholic Beverage Control Board approved the exemption on Monday, and then quickly moved to approve the new store’s liquor license. Board members voted without opposition to ...

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 ...

CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of ...

AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) for accelerated approval for ...