FDA Updates

Previously, IgG-hyaluronidase recombinant was approved by the FDA in 2014 for the treatment of primary immunodeficiency in adult patients and has expanded to include some pediatric patients.

The approval was based on the results of a phase 3 trial that found an improvement in progression-free survival among individuals treated with pembrolizumab.

BrainSee creates a new standard for progression prediction in Alzheimer disease, marking a step forward in brain health management with non-invasive screening.

The accepted sBLA comes after phase 3 clinical trial results which demonstrated better overall survival, progression-free survival, and confirmed overall response rate than chemotherapy in patients with cervical cancer.

Teneo Excimer Laser Platform is a new laser assistance in situ keratomileusis for vision correction surgery for those who have myopia and myopic astigmatism.

Berdazimer topical gel, 10.3% (Zelsuvmi; Ligand Pharmaceuticals Inc) has been approved for the treatment of molluscum contagiosum in individuals aged 1 year and older.

Pharmacists' expertise is crucial in educating patients about regulatory changes, helping them navigate alternative formulations, and providing insights into evidence-based choices.

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

These drugs have interesting mechanisms, unique use, or may support expanded indications in the future.

This approval makes birch triterpenes the first treatment for wounds associated with junctional epidermolysis bullosa to be approved by the FDA.

If approved, V116 would offer significant improvements in safety and effectiveness for the prevention of pneumococcal disease.

Previously, garadacimab was granted an orphan drug designation as a therapy for hereditary angioedema by both the FDA and EMA.

The approval marks the first for an alternative to platinum-containing chemotherapy.

Belzutifan (Welireg; Merck) demonstrated superior progression-free survival compared to everolimus in advanced renal cell carcinoma.

The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.

Officials from the FDA have granted Geron Corporation’s imetelstat fast track designation for adult patients with intermediate-2 or high-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.