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FDA Approvals

Date Posted
Article Title
FDA Approves First Oral Drug for Spinal Muscular Atrophy

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

New IV Opioid Approved for Use in Controlled Settings

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

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

VESIcare LS Approved for Neurogenic Detrusor Overactivity

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

FDA Approves IV Artesunate for Severe Malaria

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

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

Pemazyre Approved for Treatment of Advanced Cholangiocarcinoma

Drug indicated for locally advanced or metastatic cholangiocarcinoma and tumors with FGFR2 fusion or rearrangement

Tukysa Approved for Unresectable, Metastatic HER2-Positive Breast Cancer

Drug indicated for patients who have previously received treatment with one or more anti-HER2-based regimen

FDA Approves First Therapy for Low-Grade UTUC

Jelmyto provides alternative to patients with low-grade upper tract urothelial cancer

FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1

Approval based on data showing 66 percent overall response rate

Epclusa Approved for Children With Any Hep C Genotype

Supplemental application of Epclusa approved to treat HCV in children without cirrhosis, with mild cirrhosis

Ofev Approved for Chronic Fibrosing ILDs With Progressive Phenotype

Approval based on data showing slowed decline in lung function compared with placebo