Approvals

It takes on average five years before the confirmatory trial is even started.

Nourianz (istradefylline) was given the thumbs-up as an add-on treatment to levodopa/carbidopa in adults with Parkinson’s disease who experience “OFF” episodes.

The U.S. FDA gave Nabriva Therapeutics a thumbs-up for both its oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.

AbbVie’s JAK inhibitor Rinvoq was approved by the U.S. Food and Drug Administration for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

The U.S. Food and Drug Administration approved Impact’s Inrebic for the treatment for adult patients with certain types of myelofibrosis, cancers of the bone marrow.

The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

The FDA approved Wakix for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.

TB Alliance became the first nonprofit organization to win regulatory approval from the U.S. Food and Drug Administration for a new drug aimed at treating some of the most drug-resistant forms of tuberculosis.

Merck’s Keytruda has become one of the best-selling drugs in the world. Last year, it generated more than $7 billion in revenue for Merck and that is only predicted to grow, particularly as the drug wins approval for new indications.

Today it was announced that the U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ prefilled syringes for Eylea.