News

FDA Approval of Amgen's UPLIZNA for IgG4-related Disease Opens New Market Opportunity in Rare Autoimmune Segment | DelveInsight
IgG4-related disease (IgG4-RD) is a systemic fibroinflammatory condition marked by the accumulation of IgG4-positive plasma ...
BioSpace8d
Amgen’s Uplizna Deepens Response Through 1 Year in Myasthenia Gravis
Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be ...
BioSpace14d
Amgen Wins Expansion for Uplizna as First Drug for IgG4-Related Disease
The FDA approved Amgen ’s anti-CD19 therapy Uplizna Thursday for use in patients with IgG4-related disease. Uplizna is the ...
Amgen: The Biotech That Knows How To Make Money
Amgen's strategic growth through M&A and R&D investments has led to a diversified portfolio. Find out why I give AMGN stock a ...
Amgen stock rises following FDA approval of UPLIZNA
The FDA’s decision to grant Breakthrough Therapy Designation to UPLIZNA underscores the significant unmet medical need in ...
Fierce Pharma14d
Amgen wins key rare disease nod for Uplizna, checking off one goal in expansion push
With a label expansion for Uplizna pushing the drug into an untouched rare disease market, Amgen is getting its money’s worth ...
FDA Approves Amgen's Uplizna As First Drug For Chronic Immune-Mediated Fibroinflammatory Disorder
The FDA approved Amgen's Uplizna as the first treatment for IgG4-RD. The decision is backed by the MITIGATE trial, showing reduced flares and sustained efficacy.
The Pharma Letter14d
Amgen’s Uplizna first FDA-approved drug for Ig4A-RD
The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults ...
PMLive14d
Amgen’s Uplizna approved by FDA as first treatment for rare disease IgG4-RD
Amgen’s Uplizna (inebilizumab-cdon) has been approved by the US Food and Drug Administration (FDA) as the first treatment for adults with immunoglobulin G4-related disease (IgG4-RD), a rare ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
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 ...