FDA News

Axatilimab in 9 mg and 22 mg vial sizes are expected to launch in early February for the treatment of chronic graft-versus-host disease.

The approval is based on data from the phase 3 VIVID-1 study and marks mirikizumab’s second approval in IBD, the first being ulcerative colitis in 2023.

Submission of the supplemental NDA was based on positive findings from the FINEARTS-HF trial investigating finerenone for heart failure with an LVEF ≥40%.

4D-150 shows promising efficacy and safety in DME as FDA greenlights Phase 3 trial for Biologics License Application submission.

After accepting the avacincaptad pegol sNDA on January 6, 2025, the FDA has set a target action date for February 26.

The designation follows positive topline data from the phase 2a trial of CNP-104 in PBC, which were presented at AASLD’s The Liver Meeting

In this edition of HCPLive’s newsletter on monthly US Food and Drug Administration (FDA) news, we cover updates from across therapeutic pipelines in December.

To celebrate the close of 2024, we're recapping the 10 most popular approval articles across the HCPLive Network of brands.

The field of allergy medicine this year saw a variety of developments, including the FDA approvals of neffy and omalizumab as well as new data on immunotherapy.

This Year in Review features 2024 psychiatry highlights: FDA approvals, MDMA-assisted therapy setback, MM120 breakthrough, new CPT codes, and advances in schizophrenia treatments.

The proposed rule seeks to establish and require standardized testing methods to detect and identify asbestos in cosmetic products with talc.

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 FDA has accepted the NDA for TNX-102 SL, a non-opioid, centrally acting analgesic, for the bedtime treatment of fibromyalgia; the PDUFA date still needs to be assigned.

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.

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.