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On July 20, GlaxoSmithKline (GSK) and Medicines for Malaria Venture announced that the US FDA has approved the marketing of its Krintafel (tafenoquine) for the treatment of P. vivaxmalaria.
This is the first new drug to prevent Plasmodium vivax malaria, and the 23rd new drug approved by the US FDA this year.
The approved Krintafel (tafenoquine) is a derivative of 8-aminoquinoline that is therape…
The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with…
July 13, 2018, The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.
“To address the risk of bioterrorism,…
On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Approval was based on a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453) in 577 patient…
On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Approval was based on a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453) in 577 patient…
Zemdri (plazomicin) is used in adult patients with complex urinary tract infections (cUTI, including pyelonephritis) caused by certain Enterobacteriaceae bacterial infections with very limited or no treatment options. This drug is an intravenous infusion drug. , once a day.
Zemdri was approved based on a multinational, double-blind, non-inferiority trial in which a total of 609 adult patients wit…
June 25, 2018, The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the fir…
On June 13, the FDA approved moxidectin for the treatment of onchocerciasis (river blindness) in patients 12 years of age and older by oral administration of 8 mg per day (4 tablets of 2 mg tablets).
Onchocerciasis is the second leading cause of blindness in the world following trachoma, mossy dermatitis, subcutaneous nodules and visual impairment caused by parasitic nematodes parasitic on human…
Rheumatoid arthritis is a chronic, prone to progressive arthritis that is very painful. Currently, TNF inhibitors are a common rheumatoid arthritis therapy, but about two-thirds of patients are unable to get clinical remission from the first treatment. And over time, a large number of patients are unable to maintain the efficacy of the drug. Therefore, these patients urgently need an innovative dr…
May 24, 2018, The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an amino acid present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages. Palynziq is a novel e…
May 21, 2018, The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.
“Patients with chronic liver disease who have low platelet counts and require a procedure a…
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
Name:
Lokelma
CAS No.:
242800-27-7
Formula:
(2Na·H2O·3H4SiO4·H4ZrO6)n
Chemical Names:
Lokelma
LOKELMA is a drug for the treatment of hyperkalemia in adults.
Hyperkalemia is a condition in which the amount of potassium in the blood is too high.
How is this drug used?
LOKELMA is a powder that is mixed with water…