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Novo Nordisk submits diabetes pill for U.S. approval

Novo Nordisk submitted the company’s oral semaglutide drug, a pill that management hopes will transform the diabetes market, for approval in the United States.

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Eton Pharmaceuticals Submits NDA for DS-200

Eton Pharmaceuticals Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the injectable hospital-use product candidate DS-200 via the Rolling Review process.

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FDA Accepts NDA for FMX101 Minocycline Foam

The U.S. FDA accepted for review Foamix Pharmaceuticals Ltd.’s New Drug Application (NDA) for FMX101 for treating inflammatory lesions of non-nodular moderate-to-severe acne vulgaris.

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Sarepta announces FDA acceptance of golodirsen NDA

The Food and Drug Administration accepted Sarepta Therapeutics Inc.’s New Drug Application seeking accelerated approval for golodirsen (SRP-4053), with a regulatory action date of Aug. 19, 2019.

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FDA Rejects Alkermes’ Opioid Modulator Treatment for Depression

The U.S. FDA rejected marketing approval of Alkermes’ major depressive disorder treatment ALKS-5461.

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AVEO Oncology Delays NDA for Kidney Cancer Drug

Shares of AVEO Oncology plunged 45 percent after the Cambridge, Mass.-based company accepted the recommendation of the U.S. Food and Drug Administration to not seek regulatory approval of the kidney cancer drug Tivozanib at this time.

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FDA Rejects Sunovion’s Parkinson’s Disease Drug

The U.S. Food and Drug Administration rejected Sunovion Pharmaceuticals’ experimental treatment apomorphine sublingual film (APL-130277) for OFF episodes of Parkinson’s disease.

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Sanofi Unloads Programs to Acer Therapeutics and MyoKardia

Acer Therapeutics in-licensed the clinical-stage, selective, non-peptide tachykinin NK3 receptor antagonist osanetant from Sanofi. MyoKardia regained global rights to all the programs that the company had inked with Sanofi.

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Acer Therapeutics Announces FDA Acceptance of NDA and Priority Review for Edsivo for Treatment of vEDS

The U.S. Food and Drug Administration accepted for review Acer Therapeutics Inc.’s New Drug Application for Edsivo for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen mutation.

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FDA approves TherapeuticsMD’s menopause drug

The U.S. Food and Drug Administration approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats.

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