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Vaping-related lung disease cases rise, case reporting standardized
All cases appear linked to e-cigarette product use, but the cause of the respiratory illnesses is still unconfirmed.
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FDA approves Turalio for symptomatic tenosynovial giant cell tumor
Turalio is the first therapy approved for the rare joint tumor and is available only through the Turalio Risk Evaluation and Mitigation (REMS)...
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FDA approvals permit double-immunoassay approach to Lyme disease diagnosis
The streamlined approach to diagnosis may speed treatment of Lyme disease.
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FDA approves Xpovio for relapsed/refractory multiple myeloma
The oral therapy was approved for patients who have received at least four prior therapies and whose disease is resistant to several other forms...
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FDA approves IB-Stim device for abdominal pain in adolescents with IBS
Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS.
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FDA issues final guidance on seeking licensure for interchangeable biologics
Biologics deemed “interchangeable” will be able to be substituted without the involvement of the prescriber.
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Ruzurgi approved for Lambert-Eaton myasthenic syndrome in patients under age 17
The approval is the first for a LEMS treatment specifically for pediatric patients.
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FDA approves congenital CMV diagnostic test
The Alethia CMV Assay Test System detects CMV DNA obtained via a saliva swab.
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Reducing asthma, COPD exacerbations in obese patients
SAN ANTONIO - Obese patients with asthma or COPD typically have metabolic and inflammatory profiles that differ from those of nonobese patients...
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Predicting treatment response in leiomyosarcoma, liposarcoma
Aberrations in oncogenic pathways and immune modulation influence treatment response in patients with metastatic leiomyosarcoma or liposarcoma.
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FDA authorizes ClonoSEQ to detect MRD in ALL, myeloma
The assay is the first next generation sequencing–based test to be granted marketing approval for detecting minimal residual disease in patients...
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SEAL: Selinexor extends PFS in advanced dedifferentiated liposarcoma
The statistical significance of the improvements varied depending on how progression-free survival was measured.