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May 17, 2018, The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine at…
May 16, 2018, The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use d…
Akynzeo is a compound intravenous injection of the 5-HT3 receptor antagonist palonosetron and the NK-1 receptor antagonist fosnetupitant to prevent nausea and vomiting in chemotherapy patients with cancer.
Palonosetron was approved in 2008 for the prevention of nausea and vomiting in the acute phase (within 24 hours) after the start of cancer chemotherapy. Fosnetupitant is a new drug used to preve…
April 17, 2018, The U.S. Food and Drug Administration today approved Crysvita (burosumab-twza), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of phosphorus in the blood. It leads to impaired bone growth and development in children and adolescents and problems with bone minera…
What is the drug for?
ILUMYA is a drug for treatment of moderate to severe plaque psoriasis, in adults, who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
Name:
Tildrakizumab
CAS No.:
1326244-10-3
Chemical Names:
GTPL8093; MK-3222
How is this drug used?
ILUMYA is an injection given under the skin. The firs…
March 6, 2018, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).Trogarzo is admi…
What is the drug for?
SYMDEKO is a drug for the treatment of cystic fibrosis (CF) in patients 12 years and older, who have specific gene mutations.
CF is a serious genetic disorder that results in the formation of thick mucus that builds up in the lungs and other parts of the body. This can lead to severe breathing problems.
Name:
Symdek(Tezacaftor, ivacaftor)
CAS No.:
1152311-62-0…
What is the drug for?
BIKTARVY is a drug for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. BIKTARVY is a combination of three antiviral drugs in a single tablet: bictegravir (new drug for HIV-1 treatment), emtricitabine, and tenofovir alafenamide (previously approved for HIV-1 treatment).
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).…
January 26, 2018, The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated…
On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Approval was based on two identical, double-blind, placebo-controlled trials, FIT-1 (NCT02076…
The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial tr…
March 20, 2018, The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
“Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 ye…