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The decision was based on the findings of the open-label, multi-cohort, multicenter, phase 1b/2 clinical trial EV-103/KEYNOTE-869. Patients who participated in the study and were included in the current analysis had locally advanced or metastatic disease, were ineligible for cisplatin-containing chemotherapy, and had not previously received systemic therapy. The primary efficacy outcome measures for the study were the objective response rate (ORR) and duration of response (DoR), which were determined by an independent central review using RECIST v1.1. The ORR for the 121 patients treated with the combination was 68%, with 12% having a complete response. The median DoR for dose escalation was 22 months for two cohorts but not for a third.

According to the FDA, more than 101,000 fatal overdoses were reported during the 12-month period that ended in October 2022. Nearly half of fatal overdoses involve bystanders, but naloxone is only used in a small percentage of those situations. According to medical professionals who support the approval, there would be a critical opportunity to close this gap and lower the number of opioid-related deaths if naloxone were available over-the-counter.

The Food and Drug Administration has approved digital therapeutics, but insurance coverage has remained a problem. Some businesses have pushed for patient pharmacy benefits to pay for their software-based therapies, but AppliedVR is going in a different direction. A new HCPCS (Healthcare Common Procedure Coding System) code that describes the company’s treatment as a virtual reality cognitive behavioral therapy device with pre-programmed therapy software was granted by CMS to the company. The program complied with all five criteria set forth by CMS to qualify as durable medical equipment.

The Abbott Alinity I TBI test is a laboratory-based test that measures ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein, two biomarkers in the blood that have been linked to brain injury when present in high concentrations. The test has a sensitivity of 96.7% and a negative predictive value of 99.4%. The availability of a blood test provides clinicians with an objective method to quickly evaluate patients with mTBIs while eliminating the need for a head CT scan, potentially reducing health care costs and minimizing emergency department wait times.

The Nerivio device is worn on the arm and uses painless electrical stimulation to activate peripheral nerves, thereby inducing a conditioned pain modulation response. It is controlled by a smartphone app and is recommended to be used every other day for migraine prevention.

The every-other-month intra-ocular injection shows a reduction in lesion growth that increases over time. The ocular formulation of the drug, previously approved for paroxysmal nocturnal hemoglobinuria, should be available in specialty pharmacies in March 2023.