The FDA has cleared IB-Stim as the first treatment specifically indicated for pediatric functional dyspepsia and related nausea, providing a noninvasive neuromodulation option for abdominal pain in patients aged 8 to 21 years.
The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
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Health Secretary Robert F. Kennedy, Jr. discusses upcoming 4-page dietary guidelines directing Americans to 'eat whole food' with major reforms, promising an early release before August.
Selarsdi (ustekinumab-aekn) was approved by the FDA as an interchangeable biosimilar to Stelara (ustekinumab) for all approved indications, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
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 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.