FDA News

Neurocrine Biosciences was granted Priority Review designations for two crinecerfont NDAs focused on children, adolescents, and adults with classic CAH.

Mirum Pharmaceuticals submitted an NDA for chenodiol tablets to treat CTX based on positive phase 3 RESTORE trial results.

The marketing authorization makes the Xpert HCV test and GeneXpert Xpress System the first point-of-care test for diagnosing HCV.

Ensifentrine, a PDE3 and 4 inhibitor from Verona Pharma, was associated with significantly improved lung function and reduced COPD exacerbations over 24 weeks.

The FDA accepted the NDA for olezarsen, an RNA-targeted medicine, in familial chylomicronemia syndrome for priority review, with a PDUFA date set for December 19, 2024.

FDA accepts a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, with a PDUFA date of February 8, 2025.

The announcement follows the release of the RhodoLED XL red light-emitting lamp, to be used in combination with aminolevulinic acid hydrochloride topical gel, 10% for actinic keratoses

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.