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The first personalized treatment for patients with metastatic bladder cancer and susceptible fibroblast growth factor receptor genetic alterations was granted accelerated approval by the U.S. Food and Drug Administration

FDA Approves Personalized Tx for Metastatic Bladder Cancer

Balversa indicated for treatment of bladder cancer with FGFR3 or FGFR2 genetic alteration
Evenity (romosozumab-aqqg) was approved for the treatment of osteoporosis in postmenopausal women with a high risk for fracture

FDA Approves Osteoporosis Tx for High-Risk Postmenopausal Women

Boxed warning states increased risks for cardiovascular death, stroke, heart attack
The U.S. Food and Drug Administration is warning patients not to use preowned test strips or test strips not authorized for sale in the United States because of possible infection or inaccurate results that could cause serious harm.

FDA Warns Against Use of Preowned or Unauthorized Test Strips

Unauthorized, preowned test strips could cause infection, inaccuracy
The U.S. Food and Drug Administration has announced the approval of Dovato (dolutegravir and lamivudine)

First Two-Drug Regimen Approved for HIV-1 Treatment

Dovato indicated for use in patients with no history of antiretroviral treatment
U.S. Food and Drug Administration approval of Ibrance (palbociclib) capsules has been widened to include men with hormone receptor-positive

Ibrance Approval Expanded to Include Men With Breast Cancer

Kinase inhibitor approved in combination with endocrine therapy for male patients with breast cancer
Dangerously high levels of heavy metals have been found in dozens of kratom products

FDA: High Levels of Heavy Metals Found in Kratom Products

Products contain levels of lead and nickel at concentrations that exceed safe daily intake
Mavenclad (cladribine) tablets were approved to treat adult patients with relapsing-remitting and active secondary progressive multiple sclerosis (MS) who have inadequately responded to or cannot tolerate an alternate drug for MS

FDA Approves Mavenclad for Treating Multiple Sclerosis

Treatment indicated for patients with relapsing-remitting, active secondary progressive MS
Jatenzo (testosterone undecanoate)

FDA Grants Approval for Hypogonadism Treatment

Jatenzo indicated for men with low testosterone due to certain conditions
Cimzia (certolizumab pegol) injection has been approved to treat adults with nonradiographic axial spondyloarthritis with objective signs of inflammation

Cimzia Injection Approved for New Inflammatory Arthritis Indication

FDA grants approval for first treatment for nonradiographic axial spondyloarthritis
Mayzent (siponimod) pills have been approved by the U.S. Food and Drug Administration for adults with relapsing multiple sclerosis.

FDA Approves Mayzent for Relapsing Multiple Sclerosis

Oral medication must be dispensed with important information about the drug's uses and risks