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Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome.

FDA Approves Firdapse for Rare Autoimmune Disorder

First agency-sanctioned treatment for adults with Lambert-Eaton myasthenic syndrome
Xospata (gilteritinib) tablets were approved today by the U.S. Food and Drug Administration for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with an FLT3 mutation

FDA Approves Treatment for AML Patients With Gene Mutation

Expanded approval also granted to mutation assay used to detect FLT3 mutation in AML patients
Truxima (rituximab-abbs) has been approved by the U.S. Food and Drug Administration as the first biosimilar to the non-Hodgkin's lymphoma drug Rituxan

FDA Approves First Biosimilar to Non-Hodgkin’s Lymphoma Drug

Truxima approved to treat adults with CD20-positive, B-cell non-Hodgkin's lymphoma
In addition to many other health risks

FDA: Kratom Products Have High Levels of Heavy Metals

New concern added to list of the agency's warnings about the herbal supplement
A major update of the United States' system for approving medical devices was announced yesterday by the Food and Drug Administration.

FDA to Update Medical Device Approvals Process

Revised process will ensure new medical devices meet safety and effectiveness standards
Vitrakvi (larotrectinib) has been approved by the U.S. Food and Drug Administration to treat adult and pediatric patients whose cancers have a specific genetic feature.

FDA Approves Vitrakvi for Cancers With Certain Genetic Trait

Drug targets solid tumors with NTRK gene fusion without a known acquired resistance mutation
The U.S. Food and Drug Administration recently announced the approval of Daurismo (glasdegib) tablets for use in combination with a low dose of the chemotherapy cytarabine to treat newly diagnosed acute myeloid leukemia. The treatment is indicated for patients aged 75 years or older who have comorbidities that may prevent the use of intensive chemotherapy.

FDA Approves New Treatment for Acute Myeloid Leukemia

Randomized clinical trial showed significant improvement in overall survival with Daurismo
The U.S. Food and Drug Administration on Friday announced it has approved Aemcolo (rifamycin)

FDA Approves Drug for Treatment of Travelers’ Diarrhea

Aemcolo not indicated for patients with diarrhea complicated by fever and/or bloody stool
The U.S. Food and Drug Administration on Monday approved Gamifant (emapalumab-lzsg) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) in pediatric (as young as newborn) and adult patients who have refractory

FDA Approves Drug to Treat Rare Immune Disease

Gamifant first drug to be approved specifically for primary hemophagocytic lymphohistiocytosis
The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma.

FDA Approves First-Line Tx for Peripheral T-Cell Lymphoma

Adcetris approved in combination with chemo to treat systemic anaplastic large cell lymphoma