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). https://www.prnewswire.com/news-releases/abbvie-receives-fda-approval-of-rinvoq-upadacitinib-an-oral-jak-inhibitor-for-the-treatment-of-moderate-to-severe-rheumatoid-arthritis-300903053.html
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. https://www.globenewswire.com/news-release/2019/08/19/1903735/0/en/Nabriva-Therapeutics-Receives-U-S-FDA-Approval-of-Xenleta-lefamulin-to-Treat-Community-Acquired-Bacteria-Pneumonia-CABP.html
The FDA has approved Celgene’s Inrebic (fedratinib) for intermediate-2 or high-risk primary or secondary myelofibrosis. https://medcitynews.com/2019/08/fda-approves-first-drug-for-blood-disorder-myelofibrosis-since-2011/
On Monday the FDA rejected Sarepta Therapeutics’ experimental drug for Duchenne muscular dystrophy, Vyondys 53 (golodirsen) via a Complete Response Letter. https://www.biopharmadive.com/news/sarepta-surprise-fda-rejection-duchenne-vyondys-53/561200/
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. https://www.businesswire.com/news/home/20190820005233/en
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. https://news.bloomberglaw.com/health-law-and-business/moderna-gets-fda-fast-track-designation-for-zika-vaccine
FDA approvals of generic drugs has hit another record high: https://www.raps.org/news-and-articles/news-articles/2019/8/generic-drug-approvals-hit-another-record-high-as?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20|%2016%20August%202019
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