FDA News

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 part 5 of 5, experts discuss ongoing unmet needs and future research priorities in schizophrenia management.

In part 4 of 5, experts discuss medication adherence to schizophrenia treatments, particularly of xanomeline and trospium choloride capsules for schizophrenia.

In part 3 of 5, experts discuss the pivotal trials evaulating xanomeline and trospium chloride capsules (Cobenfy) for schizophrenia.

In part 2 of 5, experts discuss the unique mechanism of xanomeline and trospium choloride capsules for the treatment of schizozphrenia.

In part 1 of 5, panel moderator gives an overview of the Special Report focusing on the approval of Xanomeline and tropism chloride capsules for schizophrenia.

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.

In this latest edition of HCPLive’s monthly newsletter on recent US Food and Drug Administration (FDA) news, we highlight updates from across therapeutic pipelines.

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.

This interview with Alexis features his reaction to the approval of lebrikizumab for eczema and its significance.

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.