The FDA approved golodirsen (Vyondys 53, Sarepta Therapeutics) on 12/12/2019 for the treatment of Duchenne muscular dystrophy amenable to exon 53 skipping. We took a look at this surprise reversal of the August 2019 rejection of the drug in a post last week.
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 12-0 to recommend approval of Horizon Therapeutics’ teprotumumab in December 2019 for the treatment of Thyroid Eye Disease.
The FDA lifted the clinical trial hold for Abeona Therapeutics’ EB-101 targeting recessive dystrophic epidermolysis bullosa
The FDA designated Dermira/Roche’s lebrikizumab a Fast Track treatment for moderate-to-severe atopic dermatitis.
The FDA Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against recommending approval of Correvio’s vernakalant due to safety concerns over hypotension, arrhythmias, and conduction disturbance.
Biocryst submitted an NDA for BCX7353 in December 2019 with a hereditary angioedema indication.
Seattle Genetics plans to file an NDA and MAA for tucatinib in 1Q20.
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