A Prescription Drug User Fee Act target date of August 31, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ...
The researchers have detailed their complete findings of subcutaneous (SC) vs intravenous (IV) efgartigimod in generalized myasthenia gravis (gMG) from the phase 3 ADAPT-SC trial and initial findings ...
Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV IRAKLIA is the first ...
Sanofi SNY announced that the phase III IRAKLIA study, which evaluated a fixed-dose subcutaneous (SC) formulation of its blood cancer drug, Sarclisa (isatuximab) for the treatment of relapsed or ...
The Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Leqembi ® Iqlik ™, a once weekly lecanemab-irmb subcutaneous (SC) injection, for maintenance dosing to ...
Keytruda Qlex must be administered by a health care provider. The Food and Drug Administration (FDA) has approved Keytruda Qlex ™ (pembrolizumab and berahyaluronidase alfa-pmph) for patients aged 12 ...
The SC formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volume SC injection ...
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