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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 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
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
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
Jatenzo (testosterone undecanoate)

FDA Grants Approval for Hypogonadism Treatment

Jatenzo indicated for men with low testosterone due to certain conditions
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
Tecentriq (atezolizumab) has been approved by the U.S. Food and Drug Administration to treat adults with extensive-stage small cell lung cancer.

FDA OKs Tecentriq for Extensive-Stage Small Cell Lung Cancer

Drug now approved as first-line treatment to be used in combination with carboplatin and etoposide
The U.S. Food and Drug Administration has given its blessing to the first immunotherapy regimen for breast cancer.

FDA Approves First Immunotherapy Drug for Breast Cancer

Combo of Tecentriq and chemo given accelerated approval for triple-negative breast cancer