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 ...

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 ...

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

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 ...

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 ...

Good afternoon and welcome to today's conference call for Omeros Corporation. (Operator Instructions) Please be advised that this call is being recorded at the company's request and a replay will be ...

The FDA has previously granted orphan drug designation to VCN-01 in this indication. If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is ultimately approved by the FDA ...

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 ...

Drugmaker AstraZeneca lifted its annual sales and profit forecast for the second time this year on Tuesday, helped by strong ...

In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with priority review designation for VYVGART Hytrulo for CIDP in China. The CDE granted the Breakthrough ...

NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.

In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with priority review designation for VYVGART Hytrulo for CIDP in China. The CDE granted the Breakthrough ...