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UCB’s Nayzilam Nasal Spray Wins U.S. FDA Approval

UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.

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ViiV Submits NDA for Once-Per-Month HIV Injectable

HIV-focused ViiV Healthcare submitted a New Drug Application (NDA) to the Food and Drug Administration for potential approval of the company’s investigational combination treatment for HIV-1.

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Johnson & Johnson wins U.S. FDA approval for bladder cancer drug

Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.

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Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).

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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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