Just ahead of the Aug. 13 PDUFA date, Citius Pharmaceuticals Inc. won the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox-cxdl), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T cells and regulatory T cells. It’s also the first green light given by the FDA for r/r CTCL since 2018.

After receiving Orphan Drug Designation earlier this year, Satellos Bioscience Inc. announced that the FDA has granted Rare Pediatric Disease Designation to SAT-3247 for the potential treatment of Duchenne muscular dystrophy (DMD).

In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s approved acute myeloid leukemia drug, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas.

The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.

The U.S. FDA’s program to foster at-home health care is in its early stages and seeks to promote the development of technologies that will enable home health care services.

Meta Pharmaceuticals Inc. announced that the FDA has granted rare pediatric disease designation to its investigational new drug META-001-PH for the treatment of primary hyperoxaluria (PH), an autosomal recessive metabolic disorder in which oxalate is overproduced and deposited in the body.

The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems.

The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.

Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.