FDA Approvals

Date Posted
Article Title
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

12/19/2019
FDA Authorizes Marketing of Automated Insulin Dosing Controller

The Tandem Diabetes Care Control-IQ Technology can be used with compatible iCGMs and ACE pumps

12/19/2019
FDA Approves Padcev for Treatment of Advanced Urothelial Cancer

Drug indicated for adults previously treated with PD-1, PD-L1 inhibitor and platinum-based therapy

11/26/2019
FDA Approves First System to Insert Ear Tubes Under Local Anesthesia

Success rates of 86 and 89 percent reported for children <5, 5 to 12 years, respectively

11/26/2019
FDA Approves Oxbryta for Treatment of Sickle Cell Disease

Drug is first approved treatment that directly inhibits sickle hemoglobin polymerization

11/25/2019
FDA Approves XCOPRI for Treatment of Partial-Onset Seizures

Versus placebo, percent of seizures per 28 days reduced with 100-, 200-, 400-mg doses of XCOPRI

11/22/2019
Givlaari Approved for Acute Hepatic Porphyria

Subcutaneous injection once monthly aims to help reduce the number of porphyria attacks

11/22/2019
Calquence Approved to Treat CLL, SLL

Progression free-survival longer with Calquence versus other standard treatments

11/18/2019
Brukinsa Approved for Relapsed, Refractory Mantle Cell Lymphoma

Two clinical trials showed tumor shrinkage in 84 percent of patients

11/18/2019
11/15/2019
Fetroja Approved to Treat Complicated Urinary Tract Infections

Label warns higher mortality found in critically ill patients with multidrug-resistant Gram-negative bacterial infections

11/13/2019
Reblozyl Approved to Treat Anemia in Patients With Beta Thalassemia

Drug is first therapy approved to help reduce number of blood transfusions