The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
Conexiant
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The FDA has cleared the first blood-based test to aid in diagnosing Alzheimer’s disease, offering a less invasive alternative to positron emission tomography scans and cerebrospinal fluid testing for cognitively impaired patients.
FDA approves Brekiya®, a dihydroergotamine mesylate autoinjector for the acute treatment of migraine with or without aura and cluster headaches in adults.