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 ...
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.
Henlius and Organon announced US FDA has accepted the Biologics License Application (BLA) for HLX14, biosimilar candidate of ...
AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...
Prademagene zamikeracel (pz-cel) could be a new treatment for rare genetic disease recessive dystrophic epidermolysis bullosa (RDEB).
AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) for accelerated approval for ...
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 ...
GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global leader ...
CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and ...
HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on ...
today announced the initiation of its Biologics License Application (BLA) submission to the Drug Regulatory Authority of Pakistan (DRAP) for the conditional approval of its PIKA rabies vaccine ...