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Food and Drug Administration News

Date Posted
Article Title
8/3/2020
Tracking Vaccine Safety After FDA Approval

Researchers say vaccines are remarkably safe due to rigorous monitoring

7/27/2020
Tecartus Approved for Treatment of Mantle Cell Lymphoma

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

7/8/2020
FDA Approves Oral Treatment for Myelodysplastic Syndrome

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

7/7/2020
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

7/2/2020
6/30/2020
6/29/2020
6/16/2020
6/15/2020
6/14/2020
FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder

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

6/12/2020
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

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
VESIcare LS Approved for Neurogenic Detrusor Overactivity

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

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

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

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

5/11/2020
5/8/2020
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

5/4/2020
4/27/2020
4/27/2020
4/24/2020
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
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

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

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

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

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

4/16/2020
4/16/2020
4/14/2020
FDA Approves Koselugo for Pediatric Neurofibromatosis Type 1

Approval based on data showing 66 percent overall response rate

4/13/2020
4/13/2020
4/9/2020
4/6/2020
4/2/2020
4/2/2020
4/1/2020
3/31/2020
3/25/2020
3/24/2020
3/23/2020
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

3/17/2020
3/11/2020
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

3/10/2020
3/10/2020
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

3/9/2020
3/4/2020