FDA News

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.

The decision by the FDA follows an announcement by Biofrontera that there were no safety issues found following the submission of the medication’s supplemental New Drug Application.

A review of 5 highly anticipated FDA decisions expected by year-end, including acoramidis for ATTR-CM, olezarsen for FCS, sotagliflozin for T1D and CKD, and more.

The approval is based on findings from BLUE-C, where Cologuard Plus demonstrated sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity.

The resubmission includes positive data from a recently completed dry eye disease symptom trial requested by the FDA after a review of the previous NDA.

The designation was based on positive data from the phase 2b FASCINATE trial of denifanstat in noncirrhotic MASH with moderate to advanced fibrosis.

Ascendis Pharma has submitted a sBLA to the FDA for TransCon hGH for the treatment of adults with growth hormone deficiency.

This approval by the FDA follows positive findings from the pivotal BOREAS and NOTUS trials on adults with uncontrolled COPD.

The FDA approves Cobenfy, the first pharmacological approach to treating schizophrenia since the 1970s.

Announced on September 24, 2024, the approval marks the second treatment approved by the FDA for Niemann-Pick disease type C within one week.

The FDA has set a PDUFA target action date of May 22, 2025, for roflumilast foam 0.3% for individuals aged ≥12 with scalp and body psoriasis.

The FDA decision to accept the new drug application for delgocitinib cream is also occurring alongside the drug’s acceptance by the European Commission.

Arimoclomol, in combination with miglustat, is approved to treat neurological symptoms associated with NPC in adults and children aged ≥2 years.

The FDA declined to approve the NDA for tradipitant for the treatment of symptoms of gastroparesis, suggesting that Vanda conduct additional studies.