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U.S. Food and Drug Administration

Neogen Launches New Assays for Histamine Detection

Neogen Corporation announced  that it has launched two new assays for the detection of histamine, Reveal for Histamine and Reveal Q+ for Histamine. Reveal and...

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Patients with Locally Advanced or...

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for repotrectinib, a next-generation tyrosine...

Walgreens and Prothena Partner to Increase Access and Enrollment in Alzheimer’s Disease Clinical Trial

Walgreens and Prothena announced a collaboration to accelerate patient identification and recruitment for Prothena’s ongoing ASCENT-2 multiple ascending dose clinical trial evaluating the safety...

Torrent Pharma launches First and Only Generic Version of Keveyis Tablets in the United States

Torrent Pharma has begun shipping the generic version of Xeris's Keveyis (dichlorphenamide), 50mg tablets, following final approval from the U.S. Food and Drug Administration...

Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets

Incyte announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor,...
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