Tag: FDA Approval
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FDA Approves Exdensur: A Twice‑Yearly Shot That Could Change Life for People with Severe Asthma
Severe asthma can be frightening: sudden attacks, emergency visits, and daily limits on what you can do. On December 16, 2025, the U.S. Food and Drug Administration (FDA) approved Exdensur (depemokimab‑ulaa) as an add‑on maintenance treatment for people aged 12 and older with severe asthma characterized by an eosinophilic phenotype – a type of asthma
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FDA Approves Breyanzi for Relapsed or Refractory Marginal Zone Lymphoma
The U.S. Food and Drug Administration approved Breyanzi for adults with relapsed or refractory marginal zone lymphoma who have already tried at least two prior systemic therapies. This approval expands the list of cancers for which Breyanzi is authorized and gives patients a new option when other treatments have failed. In plain language: what is
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FDA Approves Armlupeg – New Pegfilgrastim Biosimilar
The U.S. Food and Drug Administration has approved Armlupeg™ (pegfilgrastim‑unne) as a biosimilar to Neulasta® (pegfilgrastim) for decreasing the incidence of infection manifested by febrile neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy, and for increasing survival after acute exposure to myelosuppressive radiation. This approval adds another pegfilgrastim biosimilar to the U.S. market and
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FDA Approves Ziftomenib for Acute Myeloid Leukemia
The treatment landscape for acute myeloid leukemia (AML) has recently seen a significant development with the U.S. Food and Drug Administration (FDA) granting full approval to ziftomenib (Komzifti™) for adult patients diagnosed with relapsed or refractory (R/R) AML who harbor a susceptible NPM1 (Nucleophosmin 1) mutation and have no satisfactory alternative treatment options. This landmark