News
STAY TUNED: ELIXI NEWS FROM THE WORLD
MenQuadfi is Sanofi’s Latest vaccine for the prevention of invasive meningococcal disease (MenACWY)
27 April 2020
MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate is a new Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older. “Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a…
Tukysa (tucatinib) new option of treatment of adult patients with advanced forms of HER2-positive breast cancer
18 April 2020
As part of Project Orbis, the U.S. Food and Drug Administration has approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to…
Koselugo (selumetinib), newly approved treatment of neurofibromatosis type 1 (NF1)
13 April 2020
The FDA has approved Koselugo (selumetinib) for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1), a genetic disorder of the nervous system causing tumors to grow on nerves. Koselugo is the first drug approved by the FDA to treat this debilitating,…
Sarclisa (isatuximab-irfc), new Therapy for Patients with Previously Treated Multiple Myeloma
3 March 2020
The FDA has approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa, administered through intravenous…
Ofatumumab, the new potential first-choice treatment for Relapsing forms of Multiple Sclerosis
28 February 2020
Novartis has announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of…
FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome
22 February 2020
The U.S. Food and Drug Administration has authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing FXS and is to be…
FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma
11 February 2020
Kite, a Gilead Company has announced that the U.S. Food and Drug Administration has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with…
First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User
9 February 2020
The FDA has authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user…
Givlaari (givosiran), first treatment for acute hepatic porphyria
5 February 2020
The EU Medicines Agency has recommended granting a marketing authorisation in the European Union (EU) for Givlaari (givosiran), the first treatment for acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older. Acute hepatic porphyria is a rare genetic condition in which…