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FDA Approvals

Date Posted
Article Title
6/1/2020
Tauvid Receives Approval for Tau Pathology Imaging

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

5/27/2020
FDA Approves IV Artesunate for Severe Malaria

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

5/27/2020
VESIcare LS Approved for Neurogenic Detrusor Overactivity

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

5/18/2020
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

5/11/2020
FDA Approves Retevmo for Certain Lung, Thyroid Cancers

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

5/6/2020
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

4/23/2020
FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer

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

4/20/2020
Pemazyre Approved for Treatment of Advanced Cholangiocarcinoma

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

4/20/2020
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

4/17/2020
FDA Approves First Therapy for Low-Grade UTUC

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

4/14/2020
FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1

Approval based on data showing 66 percent overall response rate

3/20/2020
Epclusa Approved for Children With Any Hep C Genotype

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

3/10/2020
Ofev Approved for Chronic Fibrosing ILDs With Progressive Phenotype

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

3/9/2020
FDA Approves Treatment for Cushing Disease

Isturisa indicated for patients who are not candidates for pituitary gland surgery or are not cured after surgery

3/3/2020
Sarclisa Approved for Treatment of Multiple Myeloma

Sarclisa combined with pomalidomide and dexamethasone indicated for patients with at least two prior therapies

2/19/2020
FDA Approves Voltaren Arthritis Pain, Pataday for OTC Use

Voltaren Arthritis Pain, Pataday Twice Daily Relief, Pataday Once Daily Relief now marketed as nonprescription drugs

2/3/2020
First Drug Approved for Treatment of Peanut Allergy in Children

Combined with peanut avoidance, treatment with Palforzia shown to alleviate allergic reactions

1/24/2020
Tazverik Approved to Treat Metastatic, Locally Advanced Epithelioid Sarcoma

Approval marks the first for a drug to treat this rare soft tissue sarcoma

1/10/2020
Ayvakit Approved to Treat GIST With PDGFRA Exon 18 Mutation

Drug is first specifically approved for GISTs harboring PDGFRA exon 18 mutation

12/23/2019
Enhertu Approved for Unresectable, Metastatic HER2+ Breast Cancer

Treatment indicated for patients who have received at least two previous anti-HER2-based regimens