The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
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.
April’s FDA approvals feature first-in-class therapies, targeted biologics, expanded indications, and innovative delivery systems across allergy, endocrinology, rheumatology, oncology, infectious diseases, and more.
The first FcRn blocker for both adult and pediatric generalized myasthenia gravis has been approved by the FDA, based on data showing sustained symptom improvement and IgG reduction in clinical trials.
The FDA approved Rinvoq (upadacitinib) as the first and only oral Janus kinase inhibitor for the treatment of giant cell arteritis in adults, providing a steroid-sparing option for achieving sustained remission.