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August 12, 2022

Generalized Myasthenia Gravis Drug Receives EU Approval Generalized Myasthenia Gravis Drug Receives EU Approval

The European Commission has granted market authorization for efgartigimod (Vyvgart, argenx) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who test positive […]
August 12, 2022

New Mismatch Repair Test Identifies Patients for Pembrolizumab New Mismatch Repair Test Identifies Patients for Pembrolizumab

The US Food and Drug Administration has approved a DNA mismatch repair (MMR) companion test to identify patients suitable for treatment with Merck’s pembrolizumab (Keytruda). The […]
August 12, 2022

FDA Approves First Drug for HER2 Lung Cancer FDA Approves First Drug for HER2 Lung Cancer

Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan […]
August 9, 2022

FDA Authorizes Intradermal Use of Jynneos Vaccine for Monkeypox FDA Authorizes Intradermal Use of Jynneos Vaccine for Monkeypox

The US Food and Drug Administration (FDA) today authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, […]
August 5, 2022

FDA Okays First Targeted Agent for HER2-Low Breast Cancer FDA Okays First Targeted Agent for HER2-Low Breast Cancer

The US Food and Drug Administration (FDA) has approved trastuzumab deruxtecan (Enhertu) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. AstraZeneca’s IV […]
August 4, 2022

White House Declares Monkeypox a Public Health Emergency White House Declares Monkeypox a Public Health Emergency

August 4, 2022 — US Department of Health and Human Services Secretary Xavier Becerra declared monkeypox a public health emergency today. There have been more than […]
August 2, 2022

Ustekinumab Becomes Second Biologic Approved for PsA in Kids Ustekinumab Becomes Second Biologic Approved for PsA in Kids

The US Food and Drug Administration has approved the dual interleukin (IL)-12 and IL-23 inhibitor ustekinumab (Stelara) for the treatment of juvenile psoriatic arthritis (jPsA) in […]
July 29, 2022

FDA Approves Topical PDE4-Inhibitor Roflumilast for Psoriasis FDA Approves Topical PDE4-Inhibitor Roflumilast for Psoriasis

The US Food and Drug Administration (FDA) has approved roflumilast 0.3% cream for the topical treatment of plaque psoriasis, “including intertriginous areas,” in patients aged 12 […]
July 29, 2022

Upadacitinib Gets European Nod for Nonradiographic AxSpA Upadacitinib Gets European Nod for Nonradiographic AxSpA

Upadacitinib (Rinvoq) has been approved by the European Commission for the treatment of active nonradiographic axial spondyloarthritis (nr-axSpA) in adults whose response to NSAIDS is inadequate, […]
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