FDA News

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.

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.

The FDA affirmed the planned NDA content and format for Anaphylm expected in Q1 2025, without requiring additional adult clinical trials before submission.

As announced by NovelMed on December 2, 2024, the FDA has granted IND clearance for Ruxoprubart to commence an efficacy trial for the treatment of IgAN.

Ustekinumab-kfce is planned for launch in February 2025 according to a previous settlement and license agreement with Janssen.

The FDA set the Prescription Drug User Fee Act (PDUFA) date for the investigational RNAi therapeutic as March 23, 2025.

With approval, acoramaidis becomes the first agent with a label specifying near-complete stabilization of TTR.

FDA grants Rare Pediatric Disease, Fast Track designations to gildeuretinol, aiming to accelerate treatment for Stargardt disease.

The sNDA was intended to include positive two-year data in the US Prescribing Information for avacincaptad pegol based on the GATHER2 clinical trial.

UCB has announced the FDA’s approval of bimekizumab, also known as Bimzelx, for patients with moderate-to-severe HS.

The announcement of the resubmission by Regeneron and Sanofi follows LIBERTY-CUPID phase 3 clinical findings on dupilumab for patients with CSU.

The acceptance of the investigational gene therapy’s Biologics License Application was announced, with the treatment designed for recessive dystrophic epidermolysis bullosa.

The CRL is consistent with the outcome of a September Gastrointestinal Drugs Advisory Committee meeting.

The announcement by the FDA resulted from an agency review of data on oral phenylephrine and a determination of its ineffectiveness as an active ingredient.

The VARIPULSE platform enables AF treatment with a single device combining pulsed field ablation therapy and mapping with the CARTO 3 system.

If approved, HLX14 would follow the first 2 denosumab biosimilar approvals in March 2024.

The approval by the FDA of minocycline hydrochloride modified release capsules, also known as DFD-29, will allow for treatment of inflammatory lesions and erythema among adults.