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Monthly News Roundup - April 2024

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on April 30, 2024.

FDA Approves First-in-Class Anktiva Plus BCG for Bladder Cancer

In April the U.S. Food and Drug Administration (FDA) approved ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln), a cancer immunotherapy for the treatment of patients with a type of bladder cancer that has not responded to treatment with the BCG (Bacillus Calmette-Guérin) vaccine.

Pfizer’s Beqvez is Cleared as a One-Time Gene Therapy for Hemophilia B

The FDA has approved Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), an adeno-associated virus vector-based gene therapy for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency). This gene therapy allows patients with hemophilia B to produce factor IX themselves rather than needing the regular intravenous (IV) infusions.

Once-Weekly Oral Ojemda First Approval for BRAF-Altered Pediatric Low-Grade Glioma

In April, the FDA granted accelerated approval to One Day Pharmaceutical’s Ojemda (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months and older with pediatric low-grade glioma (pLGG) that has come back or not responded to previous treatment and has a certain type of abnormal “BRAF” gene. Continued approval for this use may depend upon results from further clinical trials.

FDA Clears Selarsdi, the Second Biosimilar to Stelara

In April, Alvotech and Teva Pharmaceuticals announced the approval of Selarsdi (ustekinumab-aekn), the most recent biosimilar to Stelara.

Oral Antibacterial Pivya Approved to Treat Uncomplicated UTIs

This past month the FDA cleared oral Pivya (pivmecillinam), a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections (UTIs) in females 18 years and older. Pivya is indicated to treat susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

FDA Approves Zevtera, the Latest Cephalosporin Antibiotic

The FDA has approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

FDA Approves Lumisight Imaging Agent to Detect Breast Cancer Post-Lumpectomy

This past month, the FDA approved Lumicell, Inc.’s Lumisight (pegulicianine), an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.

FDA Approves Xolremdi to Treat Patients 12 and Older with WHIM Syndrome

At the end of April, the FDA approved oral Xolremdi (mavorixafor) for use in patients 12 years and older with WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome to increase the number of circulating mature neutrophils and lymphocytes, types of white blood cells that help fight infection.

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