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 ...

Credit: Getty Images. The SC formulation is intended to be administered in 10 minutes twice a year. Positive data were announced from a phase 3 trial evaluating an investigational subcutaneous (SC) ...

TOKYO and CAMBRIDGE, Mass., Nov 28, 2025 - (JCN Newswire) - - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB ...

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 ...

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 substudy, evaluating the SC formulation in an open-label extension (OLE) of the Clarity AD study*, included 72 patients who received LEQEMBI for the first time as the SC formulation, and 322 ...

The product is administered over a period of 3 to 5 minutes into the subcutaneous tissue of the abdomen or thigh by a health care provider. Opdivo Qvantig combines nivolumab, a programmed death ...

As more drugs go subcutaneous, Phillips Medisize's Tony Bedford believes that high-dose biologics will become a prevalent choice for drugmakers.

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 ...