FDA News

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.

The FDA has approved the Eversense 365, the world’s first 1-year continuous glucose monitor, with US availability expected in late 2024.

The FDA advises stopping the fezolinetant treatment at the first signs of liver injury to prevent further damage and help restore normal liver function.

Nanoscope Therapeutics announced the meeting with the FDA supported the advancement of MCO-010 into Phase 3 for Stargardt disease.

Eli Lilly’s announcement of the lebrikizumab-lbkz approval for patients 12 years of age and older follows positive findings from the ADvocate 1, ADvocate 2, and ADhere studies.

This approval expands the drug’s age range and follows recent positive phase 3 findings on dupilumab treatment for patients aged 12 to 17 with CRSwNP.

This marketing authorization by the FDA allows the Hearing Aid Feature to be implemented alongside compatible Apple AirPod Pro headphones.

The agency's designation was granted to plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.

The decision is based on rates of clinical and endoscopic remission with guselkumab in the ongoing phase 2b/3 QUASAR study.

In this episode, hosts discuss availability of the Abbott Lingo CGM and Embecta’s announcement of FDA clearance for their tubeless patch pump with a 300-unit insulin reservoir.

The FDA has granted full approval to sparsentan (Filspari) for slowing kidney function decline in adults with IgAN at risk of disease progression based on PROTECT trial data.

FDA expands Omnipod 5 AID system for type 2 diabetes, marking the first AID system approved for both type 1 and type 2 diabetes management.