FDA Updates

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

Drug targets the CD79b protein on B-cells.

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.

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.

Results from a recent ELLIPSE trial indicate superiority in reducing blood sugar when compared to the placebo.

Benlysta is the first approved treatment for children with lupus. 

Eticovo (etanercept-ykro) is a TNF blocker, biosimilar to Enbrel (etanercept). 

New lotion from Ortho Dermatologics expected June 2019. 

DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) provides LAMA/LABA therapy.

Diacomit (stiripentol) is indicated for rare, severe form of pediatric epilepsy.

Indicated for adults with moderate to severe plaque psoriasis.

Esketamine comes with close supervision requirements. 800 clinics have already been approved and dispensed initial applications.