FDA Approvals

Date Posted
Article Title
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

Nourianz Approved to Treat 'Off' Episodes in Parkinson Disease

Drug showed efficacy as add-on treatment for 'off' episodes in PD patients taking levodopa/carbidopa

New Antibiotic Approved for Community-Acquired Bacterial Pneumonia

Clinical data show similar results between Xenleta and moxifloxacin with or without linezolid

Implant Approved to Improve Symptoms in Advanced Heart Failure

Barostim Neo System indicated for patients not suited for cardiac resynchronization therapy

Rozlytrek Approved to Treat Tumors With NTRK Gene Fusion

Drug also approved to treat metastatic non-small cell lung cancer with ROS1-positive tumors