FDA Updates

Bevacizumab-bvzr is an mAb endothelial growth factor biosimilar.

Complement inhibitor is the first treatment for the rare autoimmune disorder.

First treatment approved for the condition with nasal polyps.

New features to ease injection administration. 

The first drug approved to specifically treat post-partum depression.

Approved to treat pediatric patients ages 6 years and older with cystic fibrosis

First non-insulin drug for pediatric use approved in nearly 20 years.

Indications include breast cancer, metastatic gastric cancer, and metastatic gastroesophageal junction adenocarcinoma.

Both responder and remitter patients experienced a statistically significant longer time to relapse with esketamine compared to the placebo

Zerbaxa is a cephalosporin antibacterial and beta-lactamase inhibitor combination drug originally approved for abdominal and urinary tract infections.

Patients on Emgality experienced an average of 8.7 fewer weekly episodic cluster headaches.

This thalidomide analogue is also indicated for multiple myeloma and myelodysplastic syndromes.

New indication adds to the oral antipsychotic’s portfolio of conditions.

First PIK3CA inhibitor treatment approved, along with diagnostic test.

Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy

Vitamin D analog foam indicated for topical treatment of plaque psoriasis in teens.

Oral solution now approved for adults and pediatric patients.

Update: now available from three manufacturers. 

Nayzilam is a benzodiazepine antiepileptic nasal spray.

Fragmin, a low-molecular-weight heparin dalteparin sodium injection, was approved for symptomatic venous thromboembolism.

Venetoclax, a BCL-2 inhibitor first approved in 2016, is now indicated for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Approval marks the first anti-PD-L1 therapy combination for RCC.

Ruzurgi approval for rare autoimmune disorder may be an olive branch.

Recent trial shows greater invasive disease-free survival when treated with Kadcyla , (ado-trastuzumab emtansine)

New drug combines dapagliflozin, saxagliptin, and metformin.

Two different versions of tafamadis get the FDA’s nod to treat a rare heart disease. 

Tibsovo (ivosidenib) is an isocitrate dehydrogenase1- inhibitor, originally approved in 2018.

First vaccine approved for all four Dengue virus serotypes in children and teens ages 9 through 16, but comes with major restrictions and controversy.