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The Tandem Diabetes Care t:Slim X2 insulin pump

FDA Approves First Customizable Insulin Pump

Product works by delivering insulin under the skin at set or variable rates
Cablivi (caplacizumab-yhdp) injection has been approved by the U.S. Food and Drug Administration to treat adults with acquired thrombotic thrombocytopenic purpura.

FDA Approves Cablivi for Rare Blood-Clotting Disorder

Drug approved to treat adults with acquired thrombotic thrombocytopenic purpura
The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration.

FDA Approves First Generic Version of Advair for Asthma, COPD

Medication approved to treat children aged 4 or older with asthma, adults with asthma or COPD
The first generic version of Sabril (vigabatrin) has been approved by the U.S. Food and Drug Administration to prevent complex partial seizures in adults and children aged 10 years and older with epilepsy.

FDA Approves First Generic Version of Epilepsy Drug Sabril

Generic equivalents held to same vigorous manufacturing standards as brand-name drugs
Due to the federal government shutdown

FDA Down to 5 Weeks of Funding to Review New Drug Applications

Agency cannot accept new fees or applications until the shutdown is over
Two drugs have been approved by the U.S. Food and Drug Administration for the treatment of rare blood diseases

FDA Approves Drugs for Treatment of Two Rare Blood Diseases

Elzonris approved to treat BPDCN; Ultomiris approved for paroxysmal nocturnal hemoglobinuria
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