FDA Updates

If approved, delgocitinib cream would be the first US treatment indicated for moderate to severe chronic hand eczema.

Approved with 3 new indications, bimekizumab-bkzx is the first and only interleukin-17 inhibitor approved for these diseases.

The decision expands treatment options for patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

The rare disease can result in progressive neurological symptoms and organ complications.

Amivatamab-vmjw is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directed activity.

The humanized anti-butyrophilin 3A monoclonal antibody selectively activates Vγ9Vδ2 T-cells.

The approval is based on positive results from the phase 2/3 IND.227/KEYNOTE-483 trial.

Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.

The treatment significantly reduced risk of occurrence by 25% compared with endocrine therapy alone.

Lebrikizumab (Ebglyss; Eli and Lilly Company) is a monthly maintenance injection with proven efficacy in adults and children aged 12 to 18 years.

Subcutaneous administration of atezolizumab and hyaluronidase-tqjs had similar efficacy to intravenous administration.

Guselkumab (Tremfya; Johnson & Johnson) is the first and only approved fully human and dual-acting monoclonal antibody blocking interleukin-23 and binding to CD64 receptors.

FCS is a severe, rare genetic disease in which patients have extremely high triglyceride levels, typically above 880 mg/dL.

NS-050/NCNP-03 is being developed to aid individuals with confirmed gene mutations that are treatable with exon 50 skipping therapy.

Full traditional approval follows accelerated approval of the medication last year.

Edaravone and dexborneol sublingual tablets are an innovative first drug to be designed for treatment of stroke and granted this designation.

Previously, the FDA granted fast track designation to ABD-147 (Abdera Therapeutics Inc) for extensive stage small cell lung cancer.

OBX-115 could offer further treatment options for individuals with advanced or metastatic melanoma by enhancing persistence, antitumor activity, and clinical safety of TIL cell therapy.

These companion diagnostics are poised to provide simpler and detailed insights into a patient’s genomic alternations, which could improve outcomes for patients with prostate cancer.

Bezisterim, an anti-inflammatory insulin sensitizer, will be authorized to proceed to a phase 2 clinical trial.

Mirdametinib is an oral, allosteric small molecule MEK inhibitor to treat pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Previously, the device was indicated for the management of type 1 diabetes in patients aged 2 years and older.

With diagnostic tools, oncology pharmacists and other health care providers can help to identify treatments that have the best probability of working for a specific patient.

The indication is for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were treated with at least 2 prior lines of therapy.

The proposed diagnostic agent has a long half-life, enables imaging the next day, and correlates to a longer shelf life in the pharmacy.

The acceptance will lead to vaccines that provide better protection against the KP.2 strain of SARS-CoV-2.

The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.

The bispecific CAR T-cell therapy for treatment of multiple sclerosis is the first to target both CD19 and CD20.