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FDA Approvals

Date Posted
Article Title
FDA Approves First Ebola Virus Treatment

Inmazeb approved for adults and children including newborns of mothers who test positive for Ebola virus

Drug Combo Approved for First-Line Treatment of Mesothelioma

Opdivo-Yervoy combination approved to treat adults with unresectable malignant pleural mesothelioma

FDA Approves Nucala for Hypereosinophilic Syndrome

Indicated for patients 12 years and older with HES for six months or longer and no non-blood-related cause

FDA Approves MiniMed 770G System for Young Patients With T1DM

The hybrid closed-loop diabetes management device is approved for patients ages 2 to 6 years old

FDA Approves New Rapid COVID-19 Diagnostic Test

No larger than a credit card, test is based on the same technology used to test for the flu, strep throat

Drug Granted Accelerated Approval for Rare Duchenne Muscular Dystrophy Mutation

Viltepso approved for DMD with mutation of DMD gene amenable to exon 53 skipping

New IV Opioid Approved for Use in Controlled Settings

Olinvyk indicated for short-term IV use in adults with moderate-to-severe acute pain

FDA Approves First Oral Drug for Spinal Muscular Atrophy

Evrysdi approved for at-home administration for patients ages 2 months and older with SMA

Tecartus Approved for Treatment of Mantle Cell Lymphoma

Drug is first cell-based gene therapy approved for the treatment of MCL

FDA Approves Oral Treatment for Myelodysplastic Syndrome

Inqovi is an oral outpatient treatment option for patients needing IV therapy

Rukobia Approved for Patients With Multidrug-Resistant HIV

Drug marks the first approval in a class of antiretroviral treatments for heavily treatment-experienced people with HIV

FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder

Uplizna approved for neuromyelitis optica spectrum disorder patients who are anti-AQP4 antibody positive

Tivicay Approved for Treatment of HIV-1 in Pediatric Patients

Tablets and tablets for suspension indicated for children age 4 weeks and older, weighing at least 3 kg

Tauvid Receives Approval for Tau Pathology Imaging

Radioactive diagnostic agent approved to image tau pathology in patients being evaluated for Alzheimer disease

FDA Approves IV Artesunate for Severe Malaria

Drug is first to be approved since discontinuation of quinine in 2019

VESIcare LS Approved for Neurogenic Detrusor Overactivity

Oral suspension treatment is the first approved for NDO patients as young as 2 years

Qinlock Approved as Fourth-Line Treatment for GIST

Approval based on study showing PFS of 6.3 months with Qinlock versus one month with placebo

FDA Approves Retevmo for Certain Lung, Thyroid Cancers

Approval indicated for NSCLC, medullary thyroid cancer, other thyroid cancers with RET gene alteration

FDA OKs Farxiga for Heart Failure With Reduced Ejection Fraction

The SGLT2 inhibitor is indicated for reducing the risk for CV death, hospitalization for heart failure

FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer

Approval indicated for those who have received at least two previous therapies