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 ...

FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date 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 ...

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

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 ...

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

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 ...

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 ...

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 ...

FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commerciali ...