FDA News and Regulatory Updates

The planned Phase 2 trial in IPF will focus on assessing MTX-463’s safety, pharmacokinetics, and efficacy.

The adcomm meeting is expected to happen in the first half of 2025, and means the FDA expects to miss the target PDUFA date.

Buntanetap is an oral molecule designed to inhibit the production of multiple neurotoxic proteins and is under investigation for treatment of Alzheimer Disease, Parkinson’s Disease, and other neurodegenerative diseases.

The FDA approved the addition of Guillain-Barré syndrome warnings for Abrysvo and Arexvy, citing postmarketing data suggesting an increased risk.

In an unusual step, the agency's draft guidance recommends the efficacy benchmark for drug approval while emphasizing clinical trial structure and cohort development.

Johnson & Johnson's posdinemab aims to slow tau pathology in early and preclinical Alzheimer’s disease populations.

Your daily dose of the clinical news you may have missed.

Your daily dose of the clinical news you may have missed.

In November 2024, an FDA advisory committee said the benefits of sotagliflozin do not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.

The FDA has approved the first generic once-daily GLP-1 injection for the improvement of glycemic control for type 2 diabetes in patients 10 years and up.

The black box warning, the agency's most prominent alert, follows earlier additions to the original fezolinetant label about hepatic injury and regular LFT testing.

This marks the second indication for tirzepatide in just more than a year, following its November 2023 approval for adults with obesity or overweight and weight-related medical problems.

Nemolizumab is the first approved monoclonal antibody that targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.

A phase 1b and Phase 2 study are up next for the novel potential MDD treatment.

Intra-Cellular Therapies submitted an sNDA to the FDA for lumateperone for the treatment of MDD in adults as as adjunctive therapy to antidepressants.

The Prescription Drug User Fee Act date is set for May 7, 2025.

After a 3-year negotiation, the FDA has cleared a phase 2 clinical trial assessing the use of smoked cannabis for the treatment of PTSD symptoms in veterans.

Aprocitentan is the first-and-only dual endothelin receptor antagonist approved for the treatment of systemic hypertension.

The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.

The FDA cleared Novavax to start enrolling the planned phase 3 trial after a safety concern was found to be unrelated to the combination vaccine.

Your daily dose of the clinical news you may have missed.

Oral sulopenem is the first oral penem approved in the US for treating uUTIs in women with limited options.

Pfizer announced the FDA approval on October 22 that makes Abrysvo now the RSV immunization with the broadest indication for adults, the company said.

The safety data used to update the Flublok label is from a study of more than 48 000 pregnant women across multiple flu seasons, according to Sanofi.

The FDA today accepted GSK's NDA for gepotidacin for the treatment of uncomplicated urinary tract infections in women and adolescents.