Clinical

Articles

A Prescription Drug User Fee Act action date for pegunigalsidase alfa is set for May 9, 2023.

FDA Accepts Resubmitted BLA for Fabry Disease

If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.

Salvat Submits NDA for Ear Infection Drug

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com


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


FDA Issues CRL for Therapy for Brain Metastasis from Neuroblastoma 

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 Accepts Application for Antibiotic for Drug-Resistant Infections

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

FDA Approves Second Indication for Brexafemme

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

FDA Accepts BLA for Cutaneous T-Cell Lymphoma Therapy

Rebyota is the first fecal microbiota product to prevent recurrence of C. diff infection, a serious and potentially life-threatening disease.

FDA Approves Rebyota, the First-ever Microbiota Product

If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.

FDA Accepts sBLA for Evkeeza for Children with Rare High Cholesterol 

A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.


Genentech Withdraws Tecentriq Indication for Bladder Cancer

If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.
	


Regulatory Updates