FDA News

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.

On September 12, 2023, the FDA announced it had issued warning letters to 8 companies, including CVS Health and Walgreens, for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.

The agency anticipates the decision to update monovalent formulas of the Pfizer, Moderna, and future COVID-19 vaccines to reflect circulating variants will become an annual practice.

This recall is defined by the FDA as Class I, known to be the most severe type given the use of such recalled products could result in harm to users.

Outlook Therapeutics announced receipt of the CRL exactly one year after resubmission of their BLA for ONS-5010 as a treatment for wet age-related macular degeneration, which would have been the first indication for a retinal disease given to an ophthalmic version of bevacizumab.

The approval was based on evidence showing no clinically meaningful differences between natalizumab-sztn and the reference drug in terms of safety, purity, and potency.

These approvals of generics by the FDA can help to provide for patients with ADHD or BED the same clinical benefits as well as risks as the drugs’ brand-name counterparts.

AbbVie submitted regulatory applications to the FDA and EMA for rizankizumab 1200 mg intravenous induction dose and 180 mg and 360 mg subcutaneous maintenance dose following successful Phase 3 trials INSPIRE and COMMAND.

The FDA Circulatory System Devices Panel has voted in favor of the benefit-risk profile of Recor Medical's RDN system in a 10-2 vote but declined to endorse Medtronic's system in a 6-7 vote.

With approval, aflibercept 8 mg becomes the first and only treatment approved in wet AMD and DME for immediate dosing at 8-week and up to 16-week intervals following 3 initial monthly doses.

The FDA approval of pozelimab (Veopoz) makes it the first and only treatment indicated for children and adults with CHAPLE disease.

The FDA has updated its list of UV wands, used to disinfect surfaces, to avoid due to potentially harmful levels of radiation exposure.