FDA News

This listicle highlights 5 major approvals and 5 trial updates in cardiovascular care from 2024.

The FDA's approval marks the second generic approval referencing a GLP-1 receptor agonist in as many months for the agency.

Concizumab marks the first subcutaneous injection treatment for hemophilia A or B with inhibitors, demonstrating an 86% reduction in bleeds in pivotal trial data.

Tirzepatide's approval marks the first and only prescription medicine available for adults with moderate-to-severe obstructive sleep apnea and obesity.

The FDA's decision not to approve sotagliflozin as an adjunct in T1D and CKD comes less than 2 months after a negative advisory committee meeting for the application.

The ATEV therapy, named Symvess, provides revascularization when autologous vein graft or implantation of a synthetic graft is not feasible.

Olezarsen ushers in a new era of care as the first therapy to receive FDA approval for adults with familial chylomicronemia syndrome as an adjunct to diet.

Submission of the Biologics License Application seeks approval of lerodalcibep to lower LDL-C in patients with or at risk for ASCVD and primary hyperlipidemia.

The Boxed Warning is based on the FDA’s review of a postmarketing case of serious liver injury with fezolinetant reported to the FAERS database.

The submission of roflumilast’s supplemental New Drug Application to the FDA by Arcutis follows the conclusion of the INTEGUMENT-PED and INTEGUMENT-OLE studies.

The approval of tapinarof cream (Vtama) for patients aged 2 years and older with eczema follows the positive findings in the ADORING trial program.

This approval announcement by Galderma follows the previous FDA approval of nemolizumab for prurigo nodularis.

Crinecerfont is indicated to be used with glucocorticoids to control androgen levels in adults and pediatric patients with classic congenital adrenal hyperplasia.

The FDA awarded Breakthrough Therapy Designation to Vir Biotechnology’s tobevibart and elebsiran for the treatment of chronic hepatitis delta.

An FDA review of postmarket clinical trial data revealed an increased risk of liver injury with obeticholic acid in patients with PBC without cirrhosis.

This new edition of HCPLive’s monthly newsletter on recent US Food and Drug Administration (FDA) news features highlighted updates from across therapeutic pipelines.

In the fifth and final video from this series, experts discuss future research priorities and opportunities in hidradenitis suppurativa.

In part 4 of our series, expert dermatologists discuss the safety profile of bimekizumab in HS relative to other disease states and trials.

In this video series segment, expert dermatologsts prove ide insight into the strengths and limitations of IL-17 A/F inhibition in HS.

Expert dermatologists discuss the role of IL-17 A/F inhibition in the management of hidradenitis suppurativa.

In this 5-part, expert-led series, a pair of dermatologists break down how the FDA approval of bimekizumab impacts the treatment landscape of HS.

Intra-Cellular Therapies announced they submitted a supplemental New Drug Application to the FDA for lumateperone (CAPLYTA) as an adjunctive therapy to antidepressants for MDD.

Dreem 3S is the first sleep wearable with an FDA-authorized Predetermined Change Control Plan.

Two supplemental Biologics License Applications for guselkumab were submitted to the FDA for treatment of children with plaque psoriasis and active juvenile psoriatic arthritis.