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FDA Rejects Amryt Pharma's Oleogel-S10 Application For Skin Blistering Disorder
Monday, February 28, 2022 - 2:29pm | 282Amryt Pharma Plc (NASDAQ: AMYT) has received a Complete Response Letter (CRL) from the FDA regarding Oleogel-S10 application for cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB). EB is a rare, genetic skin disease characterized by extremely fragile...
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FDA Strikes Off Reata Pharma's Bardoxolone Application For Rare Kidney Disease
Monday, February 28, 2022 - 7:09am | 285The FDA has issued a Complete Response Letter (CRL) regarding Reata Pharmaceuticals Inc's (NASDAQ: RETA) application seeking approval for bardoxolone methyl for chronic kidney disease (CKD) caused by Alport syndrome. The agency concluded that it does not believe the...
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What's Next For Apricus Biosciences' Vitaros?
Tuesday, February 20, 2018 - 10:39am | 369Apricus Biosciences Inc (NASDAQ: APRI) receded 67.4 percent Friday and continued down Tuesday after the U.S. Food and Drug Administration issued a response letter for Vitaros. The FDA declined to approve the New Drug Application after identifying safety concerns and deficiencies in the erectile...
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Analyst Remains Confident In Corium Despite Partner's Bad FDA News
Wednesday, December 27, 2017 - 12:19pm | 502The U.S. Food and Drug Administration sent an unfavorable Complete Response Letter last week to Agile Therapeutics Inc (NASDAQ: AGRX) regarding approval for the Twirla contraceptive patch. The letter also included concerns at a third-party manufacturer, Corium International Inc (NASDAQ: CORI...
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Dynavax Shares Plunge 70% Amid Complete Response Letter For Hepatitis B Drug
Monday, November 14, 2016 - 9:39am | 358Shares of Dynavax Technologies Corporation (NASDAQ: DVAX) plunged more than 70 percent after the disclosure of a Complete Response Letter (CRL) from the FDA on its Biologics License Application for HEPLISAV-B. The drug candidate is meant for immunization of adults 18 years and older affected by...