Fantastic news: Last week, the US FDA officially approved teplizumab-mzwv (Tzield), the only drug that has been demonstrated to delay the onset of type 1 diabetes. Diabetes Daily has been eagerly following Tzield for years, and last year, we supported a letter-writing campaign to the FDA in the new drug’s support. “Tzield” is the new … Read more
Dexcom Announces Global Rollout of G7, as reported by Andrew Briskin for diaTribe.org, 10 October 2022. Dexcom, one of the leading manufacturers of CGM, announced on Oct. 4 that its latest product, the Dexcom G7, is now available for people with diabetes, ages 2 and up, in five additional countries: United Kingdom, Ireland, Germany, Austria, and Hong … Read more
The Food and Drug Administration (FDA) on Wednesday authorized Covid-19 vaccine boosters for children who are five years old and above. The Moderna vaccine has been approved for children six years and older, while children as young as five can get the Pfizer vaccine. The update comes nearly a year after the Center for Disease … Read more
The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common Omicron strain. Shots could begin within days. The move by the Food and Drug Administration tweaks the recipe of shots made by Pfizer and rival Moderna that already have saved millions of lives. The hope is that … Read more
The Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Novavax COVID-19 Vaccine, Adjuvanted to include use in adolescents 12 to 17 years of age for preventing COVID-19 caused by SARS-CoV-2. Novavax COVID-19 Vaccine, Adjuvanted is engineered from the genetic sequence of SARS-CoV-2 using the Company’s recombinant nanoparticle technology to generate … Read more
The U.S. Food and Drug Administration (FDA) has ordered Pfizer Inc PFE.N to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday. The drugmaker must produce initial results of a randomized controlled trial of a second course of … Read more
Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. Instead … Read more
Final Day: Make Your Voice Heard AGAIN to the FDA re CGM! Here’s another chance to tell them, in a few short sentences, what you want, regarding CGM (continuous glucose monitoring) alarms! The FDA has mandated that CGM LOW BG alarms MAY NOT be turned off or silenced. I guess they don’t trust us to … Read more
From one of the founders of the #WeAreNotWaiting” movement: “Hey FDA, if you had been listening to us, we wouldn’t have had to overwhelm you with public comments!” This is about the Fulfillment of 21st Century Cures Act Section 3060 Required Report: Comments from People with Insulin-Requiring Diabetes, which affects all people with diabetes and their technology. … Read more
Diabetes Patients Flood FDA with Comments on Cybersecurity for Medical Devices, as reported by Mariam Baksh for NextGov.com, 8 July 2022. The Food and Drug Administration received more than a thousand comments—mainly from diabetes patients and their family members—in response to draft cybersecurity guidance for staff to use when processing submissions from medical-device manufacturers seeking … Read more