Data from the Phase two PLEIADES (MMY2040) study are also included in the
Biologics License Application. The subcutaneous formulation of DARZALEX is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's ENHANZE drug delivery technology].
Global health care company Novo Nordisk A/S (CPH:NOVOB) reported on Tuesday the approval by the US Food and Drug Administration (FDA) of the
Biologics License Application for ESPEROCT for the treatment of adults and children with haemophilia A.
Science company Pfizer (NYSE:PFE) said on Thursday that it has filed its
Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for review for its vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
The review period begins with the submission of a completed
Biologics License Application. The FDA has also granted orphan drug designation to CAMPATH.
The company's
biologics license application for the monoclonal antibody is concentrated on positive data from ICARIA-MM, an open-label phase three trial in patients with relapsed/refractory multiple myeloma.
as a
Biologics License Application (BLA) since a biosimilar approval pathway has not been established.
A
Biologics License Application is expected to be filed with the FDA in late 2005.
With the possibility for innovaTIL-04 study to be registrational, the company is "reasonably" planning a path for a
Biologics License Application submission in the second half of 2020, Pantginis tells investors in a research note.
Sanofi Pasteur has announced that the Food and Drag Administration has approved its supplemental
biologics license application for the licensure of Fluzone Intradermal influenza virus vaccine.
Food and Drug Administration (FDA) in the third quarter to complete their "rolling"
Biologics License Application (BLA).
The Company expects to file a
biologics license application for omburtamab for the treatment of CNS/LM from neuroblastoma during 2019.