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Poteligeo (mogamulizumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with two rare types of non-Hodgkin lymphoma.

FDA Approves Poteligeo for Rare Types of Non-Hodgkin Lymphoma

Drug approved to treat relapsed or refractory mycosis fungoides and Sézary syndrome
Azedra (iobenguane) has been approved by the U.S. Food and Drug Administration to treat people 12 and older with rare adrenal gland tumors (pheochromocytoma or paraganglioma) that can't be surgically removed and have spread beyond the original site.

FDA Approves Azedra for Rare Adrenal Tumors

First systemic treatment for patients who experience tumor-related symptoms such as hypertension
A magnetic system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy has been approved by the U.S. Food and Drug Administration.

FDA Approves Magnetic System for Guiding Lymph Node Biopsies

Sentimag System uses magnetic detection to identify sentinel lymph nodes for surgical removal
Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid leukemia among people with a defective IDH1 gene.

FDA Approves Tibsovo for Acute Myeloid Leukemia

Approved for adults with relapsed or refractory acute myeloid leukemia who have IDH1 mutation
Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization

Trials Supporting FDA Approval of Breakthrough Drugs Examined

Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
TPOXX (tecovirimat) has been approved by the U.S. Food and Drug Administration to treat smallpox.

FDA Approves First Drug to Treat Smallpox

New treatment offers additional option should smallpox ever be used as a bioweapon
The first generic version of an under-the-tongue film to treat opioid addiction has been approved by the U.S. Food and Drug Administration.

FDA Approves First Generic Under-the-Tongue Suboxone

May only be prescribed by Drug Addiction Treatment Act-certified prescribers
The first biosimilar drug to Neulasta has been approved by the U.S. Food and Drug Administration. Fulphila (pegfilgrastim) is approved for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy and have symptoms of febrile neutropenia.

FDA OKs 1st Biosimilar to Prevent Chemo-Related Infections

Fulphila, biosimilar to Neulasta, helps reduce risk of infection during cancer treatment
The first artificial iris has been approved by the U.S. Food and Drug Administration for patients with aniridia.

FDA Approves First Artificial Iris

CustomFlex Artificial Iris improves light sensitivity and glare, cosmetic appearance of the eye
U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis

FDA Approves New Treatment for Ulcerative Colitis

First oral medication approved for chronic use in moderate-to-severe active ulcerative colitis