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FDA Approvals

Date Posted
Article Title
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

FDA Approves Treatment for Cushing Disease

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

Sarclisa Approved for Treatment of Multiple Myeloma

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

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

First Drug Approved for Treatment of Peanut Allergy in Children

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

Tazverik Approved to Treat Metastatic, Locally Advanced Epithelioid Sarcoma

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

Ayvakit Approved to Treat GIST With PDGFRA Exon 18 Mutation

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

Enhertu Approved for Unresectable, Metastatic HER2+ Breast Cancer

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

FDA Authorizes Marketing of Automated Insulin Dosing Controller

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

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

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

FDA Approves Oxbryta for Treatment of Sickle Cell Disease

Drug is first approved treatment that directly inhibits sickle hemoglobin polymerization

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

Givlaari Approved for Acute Hepatic Porphyria

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

Calquence Approved to Treat CLL, SLL

Progression free-survival longer with Calquence versus other standard treatments

Brukinsa Approved for Relapsed, Refractory Mantle Cell Lymphoma

Two clinical trials showed tumor shrinkage in 84 percent of patients

Fetroja Approved to Treat Complicated Urinary Tract Infections

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