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STAY TUNED: ELIXI NEWS FROM THE WORLD
Glucagon for injection USP, First Generic of Drug Used to Treat Severe Hypoglycemia
8 January 2021
The FDA has approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic…
Ibrance, Palbociclib, is the #1 prescribed, FDA-approved oral combination treatment for HR+, HER2- mBC.
5 January 2021
IBRANCE® IS THE FIRST FDA-APPROVED MEDICATION in its class. IBRANCE is a targeted therapy known as a CDK 4/6 inhibitor. It is not a traditional chemotherapy. Taken in combination with certain hormonal therapies, IBRANCE works to put the brakes on cell growth in both healthy and cancer cells. This…
Libmeldy, world’s first lentiviral vector-based gene therapy for the treatment of metachromatic leukodystrophy (MLD)
22 December 2020
The European Commission officially announced full approval for the world’s first lentiviral vector-based gene therapy for the treatment of metachromatic leukodystrophy (MLD), a rare neurodegenerative disease of genetic origin: Libmeldy, the result of a collaboration between Telethon Foundation, San…
PALFORZIA® [defatted powder of Arachis hypogaea L., semen (peanuts)]approved in the EU for the treatment of peanut allergy
21 December 2020
PALFORZIA is an oral immunotherapy indicated in patients aged 4 to 17 years, who have a confirmed diagnosis of peanut allergy. PALFORZIA may be continued in patients 18 years and older and must be used in conjunction with a peanut-avoidant diet. "Today's news of the EC approval represents the…
Tagrisso (osimertinib) , First Adjuvant Therapy for Most Common Type of Lung Cancer
19 December 2020
The U.S. Food and Drug Administration has approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation. "Today’s approval of Tagrisso demonstrates how additional research on therapies approved in…
Gallium 68 PSMA-11 (Ga 68 PSMA-11)is the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
3 December 2020
U.S. Food and Drug Administration has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for patients with suspected…
European Commission Approves Janssen’s TREMFYA (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA)
26 November 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved TREMFYA®▼ (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior…
Zokinvy (lonafarnib) is the first approved Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
24 November 2020
The U.S. Food and Drug Administration has approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older. Zokinvy is not approved for…
New indication expands use of Brilinta (ticagrelor) beyond cardiovascular disease to patients with mild-to-moderate stroke
9 November 2020
AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischaemic attack (TIA). The approval…