FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma

December 2nd 2022

In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.

FDA Accepts Application for Antibiotic for Drug-Resistant Infections

December 2nd 2022

SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.

FDA Approves Second Indication for Brexafemme

December 2nd 2022

Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.

FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy

December 1st 2022

I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.

Safety Questions Follow Positive Results for Lecanemab in Alzheimer’s

December 1st 2022

Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.