Top Regulatory News Stories – Week Ending August 23, 2019

AbbVie announced that the U.S. FDA has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

Nabriva Therapeutics announced that the FDA has approved the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

The FDA has approved Celgene’s Inrebic (fedratinib) for intermediate-2 or high-risk primary or secondary myelofibrosis.

On Monday the FDA rejected Sarepta Therapeutics’ experimental drug for Duchenne muscular dystrophy, Vyondys 53 (golodirsen) via a Complete Response Letter.

Vertex Pharmaceuticals announced the FDA accepted its NDA for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. The FDA has granted Priority Review of the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 19, 2020.

Moderna said the FDA granted Fast Track designation for its investigational Zika vaccine mRNA-1893 currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.

FDA approvals of generic drugs has hit another record high:|%2016%20August%202019

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