FDA News

Eli Lilly and Company announced the FDA approval of mirikizumab (Omvoh) for moderately and severely active ulcerative colitis in adults on October 26, 2023.

The FDA has issued a Class I recall for some of Fresenius Medical Care's hemodialysis machines due to potential exposure to toxic compounds, affecting eight specific models from the 2008 Series.

The FDA has granted 510(k) Clearance to the Omnipod 5 app for iPhone, making Insulet Corporation the first to offer a tubeless AID system with smartphone control.

Announced by Milestone Pharmaceuticals on October 24, 2023, the New Drug Application includes positive results on etripamil from the pivotal phase 3 RAPID trial.

Samsung Bioepis gains FDA interchangeability designation for its ranibizumab (Lucentis) biosimilar, ranibizumab-nuna (Byooviz), in the treatment of wAMD, macular edema following RVO, and mCMV

The first-of-its-kind Aurora EV-ICD system offers a single-device, single procedure with a lead placed outside of the heart and veins.

Designed to treat the acne's inflammation, bacteria and follicular hyperkeratinization, IDP-126 has shown significant efficacy compared to standard-care options already on the market.

The latest indication for the dual inflammatory pathway-targeting biologic expands dupilumab's clinical availability to third chronic skin disease.

The expanded Indication now includes children of all ages with achondroplasia, the most common form of skeletal dysplasia leading to disproportionate short stature.

Results from the phase 3 NEAR-1 and NEAR-2 clinical trials show consistent efficacy and tolerability of the preservative-free, low-dose eye drop in patients with presbyopia.

On October 17, 2023, Ardelyx Inc announced the FDA approval of tenapanor (Xphozah) for reducing serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy.

The approval of oral, once-daily etrasimod 2 mg was based on positive data from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials.

Announced on October 9, the decision to issue a CRL is based on the FDA's belief the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established.

This decision by the FDA could offer psoriatic arthritis patients a dosing regimen each month that does not require pre-mediation or regular lab assessments.

This announcement by Arcutis broadens the psoriasis drug’s indication and was done to help simplify management of the skin condition for younger patients as well.

This news was announced following new findings by the FDA due to a recent inspection, though no concerns were listed regarding clinical data, labeling, or safety.

This action represents the first occurrence of the FDA pursuing civil money penalties for the maximum amount against e-cigarette retailers for such an offense.

Data from the VISIBLE 1 trial showed more patients receiving subcutaneous vedolizumab achieved clinical remission, mucosal healing, durable clinical response, durable clinical remission, and corticosteroid-free clinical remission compared to those receiving placebo.

The FDA warns semaglutide (Ozempic) users of increased ileus risk and hypoglycemia with insulin secretagogues.

Granted a PDUFA date in March 2024, if approved, sotatercept would be a first-in-class medication to address the rare and progressive disease.

According to the approval, the percentage of study eyes returning to ≤0.2 mm from baseline pupil diameter was statistically significantly greater in the phentolamine ophthalmic solution group than placebo.

The agency’s guideline updates were announced, with the overall goal being to help food facilities in their adherence to current good manufacturing practices.

Results from EoE KIDS showed 68% of patients on a higher dose of dupilumab and 58% of patients on a lower dose achieved significant histological disease remission.

Eli Lilly and Company and Boehringer Ingelheim announced the FDA approval of empagliflozin (Jardiance) for chronic kidney disease management on September 22, 2023.

The company shared anticipation that their BLA decision for bimekizumab to treat adults with plaque psoriasis will not come before the end of this month.

Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide a breakdown of the latest news in diabetes management, including FDA clearance of a new insulin pump and a major acquisition within the diabetes world.

Ahmad Masri, MD, MS, provides his perspective on the APOLLO-B data and reacts to the FDA CRDAC 9 to 3 vote in favor of the benefit-risk profile for patisiran in ATTR-CM.

The FDA CRDAC convened on Septemeber 13 to discuss the sNDA for patisiran as a treatment for ATTR-CM, with the meeting concluding in a 9:3 vote in favor of the benefit-risk profile of patisiran.

The sNDA was announced for roflumilast cream 0.15% to the FDA, and the formulation is said to not to be disruptive to the skin barrier or contain common irritants to patients’ skin.

The advisory committee's vote may trigger an FDA decision to remove more than 250 cough medicine products from the market, or require a reformulation of such items.