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FDA Approvals

Date Posted
Article Title
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

Reblozyl Approved to Treat Anemia in Patients With Beta Thalassemia

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

FDA Approves Reyvow for Acute Migraine

In clinical trials, pain resolved at two hours in significantly more patients taking Reyvow versus placebo

Implant Approved for Patients With Phototoxic Reactions From Rare Disorder

Scenesse increases pain-free light exposure in patients with erythropoietic protoporphyria

FDA Approves Descovy for HIV-1 Preexposure Prophylaxis

Drug indicated to reduce risk for HIV-1 infection from sex excluding receptive vaginal sex

Rituxan Approved for Pediatric Patients With Rare Vasculitis Diseases

Approval of Rituxan expanded to children with granulomatosis with polyangiitis, microscopic polyangiitis

Mavyret Approved as 8-Week Treatment for Hep C, Compensated Cirrhosis

Drug approval expanded to any treatment-naive HCV patients, regardless of cirrhosis status or treatment type

FDA Approves Vaccine for Prevention of Smallpox, Monkeypox

Jynneos is approved for adults considered at high risk for infection

FDA Approves First Treatment for ILD With Systemic Sclerosis, Scleroderma

Approval of Ofev for this indication based on data from SENSCIS study