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.
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The FDA has authorized CT-132, the first prescription digital therapeutic for episodic migraine prevention, based on clinical trial data showing reduced monthly migraine days.
“Approval of an immediate-use intranasal diazepam treatment that can be given at any time—even while a child is actively seizing—in this young age group is an important advance for the epilepsy community.”
“The true or actual rate of autism [in the United States] is more likely to be closer to what this report has identified in California or Pennsylvania."
Indivior, a Virginia-based drug manufacturer, has reached an $86 million settlement with 16 U.S. states over its alleged role in the opioid addiction crisis, involving buprenorphine-based products. The settlement funds will be used for opioid addiction treatment, recovery, and prevention.