FDA News

FDA approves pitolisant for excessive daytime sleepiness and cataplexy in pediatric patients aged ≥ 6 years with narcolepsy.

The approval is based on data from a pair of phase 3 studies and makes risankizumab-rzaa the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn’s disease.

The FDA provided 510(k) clearance for the COR-12 wireless ECG device, which was now integrated with the SpiroSphere.

This approval by FDA officials allows patients an alternative option to pre-filled syringe, which had been the only choice for those with eczema prescribed tralokinumab.

The accelerated approval is based on data from the phase 3 ELATIVE trial demonstrating a reduction in alkaline phosphatase with elafibranor.

The new approval expands the treatment area by 4 times the previously approved area—from 25 cm2 to 100 cm2.

The VIO Skin Platform by Enspectra Health was designed to assess lesions indicating either basal cell carcinoma or squamous cell carcinoma.

Follow HCPLive's coverage of the full-day FDA committee meeting regarding Lykos Therapeutics' application for MDMA-assisted therapy as a novel treatment for patients with PTSD.

Emerson previews the highly anticipated FDA advisory committee this week, and Lykos' plans for rolling out MDMA-assisted therapy in the event it is approved to treat PTSD.

The FDA moved the target date for their decision on the dupilumab application by 3 months, citing a need for more efficacy data from its pivotal phase 3 trials.

The FDA approved eculizumab-aeeb (Bkemv) as an interchangeable biosimilar to eculizumab (Soliris) for treating PNH and aHUS, marking the agency’s 53rd biosimilar approval.

Announced on May 22, 2024, the Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream to evaluate cardiovascular risk.

On May 20, 2024, the FDA announced the approval of 2 products as interchangeable biosimilars to aflibercept—the first products to receive such a designation from the FDA.

Announced on May 15, 2024, the IND application supports a phase 1/2 study of CID among adults with chronic ITP.

The FDA has extended the review period for palopegteriparatide in treatment of hyperparathyroidism in adult patients by 3 months to August 14, 2024.

The CRL for the sBLA cites a lack of sufficient data to support the full evaluation of the effectiveness and safety of a 4-dose regimen in this patient population.

Geneoscopy's ColoSense received FDA approval on May 06, 2024 based on data from the phase 3 CRC-PREVENT trial.

Lykos Therapeutics' new drug application for MDMA plus psychiatric intervention for adults with PTSD will be the first reviewed by an FDA committee for such a therapy.

The April 2024 cardiology month in review spotlights FDA news and top updates from the American College of Cardiology 2024 Scientific Session.

The current approval is based on the VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm.

The decision by Eli Lilly to resubmit lebrikizumab to the FDA for adults and adolescents with eczema is expected to receive a response in the second half of the year.

FDA issued a CRL the abbreviated new drug application of ketamine, which had sought to enhance accessibility to the limited drug supply.

Abbott's Esprit BTK System was shown to significantly reduce risk of ischemic events in patients with PAD versus angioplasty over 1 year.

FDA approves mavorixafor (XOLREMDI) for WHIM syndrome, the first approved treatment for the rare disease.

The announcement by Dermavant followed positive findings from the ADORING trials on tapinarof and an open label extension for children aged 2 - 17.