FDA recalls heart drug for cancer concerns

FDA recalls heart drug for cancer concerns

A woman who’s been taking the drug for years was diagnosed with cancer, saying this recall could answer a lot of questions. Published: 11:17 PM EDT July 16, 2018 Updated: 7:17 PM EDT July 16, 2018 Source link

Karyopharm seeks FDA approval for drug in highly refractory blood cancer

Karyopharm seeks FDA approval for drug in highly refractory blood cancer

A company developing a new class of drugs for multiple myeloma is aiming for the Food and Drug Administration’s green light for its lead product candidate. Newton, Massachusetts-based Karyopharm Therapeutics said Wednesday that it had starting a rolling New Drug Application submission to the FDA for the drug, selinexor. The drug is known as a […]

Agios Pharmaceuticals Scores FDA Approval For Tibsovo, Second AML Drug Win in Less Than a Year

Agios Pharmaceuticals Scores FDA Approval For Tibsovo, Second AML Drug Win in Less Than a Year

Shares of Agios Pharmaceuticals jumped this morning after the Cambridge, Mass.-based company said the U.S.Food and Drug Administration (FDA) approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year. Tibsovo was approved for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML) with […]

FDA Approves Drug to Stop Some Malaria Relapse

FDA Approves Drug to Stop Some Malaria Relapse

U.S. regulators Friday approved a simpler, one-dose treatment to prevent relapses of malaria. Standard treatment now takes two weeks and studies show many patients don’t finish taking every dose. Malaria is caused by parasites that are spread to people through mosquito bites. Anti-malarial drugs can cure the initial infection, but parasites can get into the […]

FDA approves drug for adolescents as epidemic grows in teens

FDA approves drug for adolescents as epidemic grows in teens

MGN Image MGN Image The Food and Drug Administration has approved Truvada pre-exposure prophylaxis known as PrEP for adolescents age 13 to 24 making the HIV prevention pill more available. In 2016, youth from the ages of 13 to 24 made up 21% of all new HIV diagnoses in the U.S., according to the CDC. […]

FDA grants orphan drug status to lenabasum for dermatomyositis

FDA grants orphan drug status to lenabasum for dermatomyositis

The FDA has granted orphan drug designation to lenabasum for the treatment of dermatomyositis, a systemic autoimmune condition characterized by skin and muscle involvement, according to a press release from Corbus Pharmaceuticals. An estimated 1 in 100,000 individuals in the United States are affected by dermatomyositis, according to the National Organization for Rare Disorders, with […]

FDA Grants Orphan Drug Designation to Dermatomyositis Treatment, Lenabasum

FDA Grants Orphan Drug Designation to Dermatomyositis Treatment, Lenabasum

First Targeted Treatment Approved for Relapsed and Refractory Acute Myeloid Leukemia By Krista Rossi The US Food and Drug Administration (FDA) has approved the first drug in its class (IDH1 inhibitors), ivosidenib (Tibsovo), for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug us […]

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