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 ...

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

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

Henlius and Organon announced US FDA has accepted the Biologics License Application (BLA) for HLX14, biosimilar candidate of ...

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 ...

By Maggie Fick and Yadarisa Shabong (Reuters) -Drugmaker AstraZeneca lifted its annual sales and profit forecast for 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 ...

GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global leader ...

HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

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 ...