FDA News

Ann Marie Navar, MD, PhD, discusses the groundbreaking approval of the first oral PCSK9 inhibitor and what it means for patients managing their LDL-C levels.

FDA accepted Camurus’ resubmitted CAM2029 application for acromegaly, with a target action date of December 18, 2026.

The FDA granted traditional approval to Novartis’ iptacopan (Fabhalta) for adults with primary IgA nephropathy, supported by phase 3 APPLAUSE-IgAN data showing slowed kidney function decline and sustained proteinuria reductions.

FDA approved once-daily oral enlicitide to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

FDA grants priority review to obinutuzumab, positioning it as the first potential approved therapy for primary membranous nephropathy.

Catch up on some of the biggest FDA news, clinical trial updates, and featured HCPLive coverage from the first half of 2026.

The supplemental New Drug Application for Arcutis’ roflumilast cream 0.05% (Zoryve) is for mild to moderate atopic dermatitis in those down to 3 months.

Review the biggest gastroenterology news from the first half of 2026, including FDA updates, IBD advances, and key clinical trials.

The FDA granted accelerated approval to atacicept to reduce proteinuria in adults with primary IgAN at risk for disease progression

FDA grants Priority Review to Agios’ mitapivat sNDA for sickle cell disease, with a PDUFA date set for November 1, 2026.

Here are 7 of the biggest nephrology stories from Q2 of 2026!

Phase 3 RAPIDe-3 data show rapid, sustained relief of hereditary angioedema attacks; PDUFA date set for April 23, 2027.

A review of 9 novel drugs approved by the US Food and Drug Administration during the second quarter of 2026.

Exagamglogene autotemcel (Casgevy) is now the first CRISPR-based gene-editing therapy to reach this age group in either condition.

Catch up on the nephrology headlines you missed in June 2026.

A review of 22 novel drugs approved by the US Food and Drug Administration during the first half of 2026, with links to coverage from MJH Life Sciences publications.

This FDA News Month in Review provides a round-up of regulatory decisions from June 2026.

The status was granted off of data from Swedish snus — a smokeless tobacco product with similar use topography, nicotine content, pH, and systemic nicotine exposure.

FDA sends fresh CRL for Unicycive’s OLC; manufacturing inspection delays approval, while data support a lower pill-burden phosphate binder.

FDA approves steroid-free roflumilast cream for plaque psoriasis in children age 2+, bringing once-daily option for sensitive areas.

The FDA has approved veligrotug-vvze for thyroid eye disease regardless of activity or duration.

Preview the biggest anticipated FDA decisions of Q3 2026, including atacicept for IgAN, mRNA flu vaccine, Furoscix ReadyFlow, and more.

FDA approved risankizumab for children aged 6 years or older with plaque psoriasis or active psoriatic arthritis.

The US FDA has approved olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.

FDA cited manufacturing and labeling issues in its CRL for cytisinicline, with no clinical efficacy or safety deficiencies reported.