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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
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
A new version of an over-the-counter asthma inhaler that was taken off the market in 2011 has been approved by the U.S. Food and Drug Administration.

FDA Approves New Version of OTC Primatene Mist

Primatene Mist approved to provide temporary relief for symptoms of mild, intermittent asthma
Ruling against the recommendation of one of its chief experts

FDA Approves Powerful New Opioid Despite Criticisms

Dsuvia use restricted to operating rooms or on the battlefield
For the first time in nearly two decades

FDA Approves First New Influenza Drug in 20 Years

Antiviral drug reduces symptoms of uncomplicated influenza when taken within 48 hours of onset