Joenja is already approved ... starting with FDA, to expand the label to be able to treat younger patients with APDS. In addition to our work in APDS, we are developing leniolisib for primary ...

The answer is that Pharming was granted the PRV by the FDA after it claimed approval for Joenja (leniolisib), a therapy for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare and ...

The National Institute for Health and Care Excellence (NICE) has recommended Pharming’s Joenja (leniolisib) to treat patients ... and Healthcare products Regulatory Agency’s approval of the drug in ...

Joenja® (leniolisib) marketed in the U.S. - the first and only ... We anticipate the trial to read-out in 2027 with potential FDA approval by end of 2028. Ms. Inés Bernal was appointed Chief People ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease ...

The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...

Continued FDA approval depends on Phase 3 ALIGN study results in 2026. Feel unsure about the market’s next move? Copy trade alerts from Matt Maley—a Wall Street veteran who consistently finds ...

The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the ...

The US Food and Drug Administration (FDA) has approved the B-cell depleting agent inebilizumab-cdon (Uplizna, Amgen) for the treatment of immunoglobulin G4-related disease (IgG4-RD). This is the ...

The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said ...