FDA Updates

Injection for leading cause of severe vision loss and legal blindness.

First new treatment of its kind in over 20 years.

For granulomatosis with microscopic polyangiitis in children.

Now approved for risk reductions in patients with type 2 diabetes mellitus.

Will be part of the U.S.’s public health emergency medical supplies and pharmaceuticals.

Monoclonal antibody for autoimmune and neurodegenerative disorders.

Now approved in 7mg and 14 mg tablets.

Derived from cultured adult bone marrow-derived mesenchymal stem cells that have undergone temporary genetic modification.

Monoclonal antibody shows potential for lupus nephritis treatment.

NHE3 inhibitor administered as 50 mg oral tablets.

Investigational oral MET kinase inhibitor from Merck.

Oral supplements for metabolic disorder. 

First generic specialty injections approved for Novadoz Pharmaceuticals. 

Cariprazine demonstrated greater improvement on the MADRS.

New pleuromutilin antibiotic IV and oral tablets.

Humira successor indicated for adults with inadequate response or intolerance to methotrexate.

First new drug approval for the condition in nearly a decade. 

Kinase inhibitor oral capsules.

Black box warns of increased risk of blood clots and death.

TNF blocker biosimilar to Humira (adalimumab, Abbvie).

CD20-directed antibody indicated for several cancers and other conditions.

Distributed by Invagen, a subsidiary of Cipla Ltd.

Fourth indication for the drug since 2014.

Combination drug indicated for infections caused by susceptible gram-negative bacteria.

First oral drug for advanced or metastatic bladder cancer.

Fourth approval for use in assessing myocardial perfusion and late gadolinium enhancement.

COMT inhibitor to be used as an adjunctive treatment to levodopa/carbidopa.

Nuclear export inhibitor indicated in combination with dexamethasone.