Tag: FDA

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Type 2 Diabetes: Automated Insulin Dosing Device approved by FDA

FDA has approved the first device for automated insulin dosing for Type 2 Diabetes condition.   This follows expansion of indication of Insulet SmartAdjust technology...

Epinephrine (or Adrenaline) Nasal Spray for Treatment of Anaphylaxis 

Neffy (epinephrine nasal spray) has been approved by the FDA for the emergency treatment of Type I allergic reactions including life-threatening anaphylaxis. This provides...

FDA approves Tecelra (a T cell receptor gene therapy) for Synovial Sarcoma 

Tecelra (afamitresgene autoleucel), a gene therapy for the treatment of adults with metastatic synovial sarcoma has been approved by the FDA. The approval was...

Antibiotic Zevtera (Ceftobiprole medocaril)  approved by FDA for treatment of CABP, ABSSSI and SAB 

The broad-spectrum fifth-generation cephalosporin antibiotic, Zevtera (Ceftobiprole medocaril sodium Inj.) has been approved by FDA1 for the treatment of three diseases viz.   Staphylococcus aureus bloodstream infections...

Rezdiffra (resmetirom): FDA Approves First Treatment for Liver Scarring Due to Fatty Liver Disease 

Rezdiffra (resmetirom) has been approved by the FDA of the USA for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to...

Iloprost receives FDA approval for Treatment of Severe Frostbite

Iloprost, a synthetic prostacyclin analog used as vasodilator to treat pulmonary arterial hypertension (PAH), has been approved by the U.S. Food and Drug Administration...

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