FDA News

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.

The 11 to 3 vote against the benefit-risk profile of sotagliflozin comes with less than 2 months to go until the December 20, 2024 PDUFA date.

The FDA originally issued a CRL requesting additional CMC data in April 2024.

On October 25, 2024, Kind Pharmaceutical announced receipt of FDA Orphan Drug Designation for AND017 in the treatment of sickle cell disease.

In the complete response letter, the FDA classified deficiencies in the Abbreviated New Drug Application for ketamine as MINOR.

Following the approval of sodium oxybate for cataplexy in adults with cataplexy, the FDA approves this indication for the pediatric population.

The FDA has extended its review of the sNDA, delaying the previous October 15, 2024, PDUFA date, without providing a new anticipated action date.

The Accure Laser System is indicated for long term treatment of patients known to have mild to severe inflammatory acne vulgaris.

Antonio Anzueto, MD, discusses how dupilumab fits into treatment algorithms for patients with uncontrolled COPD.

Stephanie Christenson, MD, discusses the impact of recent regulatory approvals and pipeline movement for chronic obstructive pulmonary disease.

The ustekinumab biosimilar will be available in early 2025, with indications to treat psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

The sNDA submission to the FDA included a Priority Review Voucher, which commits the regulatory agency to an accelerated review timeline.

The designation was granted to Mirum Pharmaceuticals based on a positive interim analysis of the phase 2b VANTAGE study of volixibat.

The FDA's decision to issue a CRL was announced on October 08, 2024 and cites issues with the timing of the facility inspection.

In addition to the Breakthrough Therapy Designation, Boehringer Ingelheim announced the initiation of 2 phase 3 trials in adults with MASH and fibrosis and compensated MASH cirrhosis.