https://cluster-site.onrender.com/tags/fda/ Recent content in Fda on Tenu Tech Brief Hugo -- 0.146.0 en-us Tue, 24 Feb 2026 06:03:56 +0000 https://cluster-site.onrender.com/posts/fda-does-u-turn-will-review-modernas-mrna-flu-shot-after-shocking-rejection/ Wed, 18 Feb 2026 17:08:18 +0000 https://cluster-site.onrender.com/posts/fda-does-u-turn-will-review-modernas-mrna-flu-shot-after-shocking-rejection/ • The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval. • Therefusal was revealed last weekin a sharply worded pre https://cluster-site.onrender.com/posts/fda-reverses-surprise-rejection-of-modernas-mrna-flu-vaccine/ Wed, 18 Feb 2026 17:08:18 +0000 https://cluster-site.onrender.com/posts/fda-reverses-surprise-rejection-of-modernas-mrna-flu-vaccine/ • The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval. • Therefusal was revealed last weekin a sharply worded pre https://cluster-site.onrender.com/posts/medtronic-earns-fda-clearance-for-stealth-axis-spinal-surgery-system/ Tue, 17 Feb 2026 23:54:58 +0000 https://cluster-site.onrender.com/posts/medtronic-earns-fda-clearance-for-stealth-axis-spinal-surgery-system/ • The Stealth AXiS system brings together planning, navigation, and robotics into one platform for spine surgery. • | Source: Medtronic Medtronic PLC last week announced the U.S. • https://cluster-site.onrender.com/posts/ocular-therapeutix-eyes-fda-filing-after-wet-amd-drug-tops-regenerons-eylea-in-phase-3-test/ Tue, 17 Feb 2026 20:09:28 +0000 https://cluster-site.onrender.com/posts/ocular-therapeutix-eyes-fda-filing-after-wet-amd-drug-tops-regenerons-eylea-in-phase-3-test/ • In the first of two Phase 3 tests, Ocular Therapeutix’s Axpaxli met the main goal of helping maintain vision in patients with the wet form of age-related macular degeneration. • https://cluster-site.onrender.com/posts/what-the-fdas-2026-wellness-device-update-means-for-wearables/ Tue, 17 Feb 2026 03:00:10 +0000 https://cluster-site.onrender.com/posts/what-the-fdas-2026-wellness-device-update-means-for-wearables/ • With more and more sensors being crammed into the consumer devices that many of us wear every day, the question of where medical devices begin and end, and how they should be reg https://cluster-site.onrender.com/posts/ptc-therapeutics-ends-bid-to-seek-fda-approval-for-rare-muscle-disease-drug/ Fri, 13 Feb 2026 19:26:09 +0000 https://cluster-site.onrender.com/posts/ptc-therapeutics-ends-bid-to-seek-fda-approval-for-rare-muscle-disease-drug/ • PTC Therapeutics said it cannot resolve differences it has with the FDA in interpreting clinical trial data for Translarna, a drug it developed for Duchenne muscular dystrophy. • https://cluster-site.onrender.com/posts/what-the-fdas-2026-update-means-for-wearables/ Thu, 12 Feb 2026 14:00:02 +0000 https://cluster-site.onrender.com/posts/what-the-fdas-2026-update-means-for-wearables/ • As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the https://cluster-site.onrender.com/posts/moderna-says-fda-refusal-to-review-mrna-flu-vaccine-contradicts-federal-rules-prior-guidance/ Wed, 11 Feb 2026 19:57:15 +0000 https://cluster-site.onrender.com/posts/moderna-says-fda-refusal-to-review-mrna-flu-vaccine-contradicts-federal-rules-prior-guidance/ • Moderna’s messenger RNA influenza vaccine succeeded in two pivotal clinical trials, but the Food and Drug Administration isrefusing to even reviewthe application seeking regulato https://cluster-site.onrender.com/posts/first-ever-inhalable-gene-therapy-for-cancer-gets-fast-tracked-by-fda/ Wed, 11 Feb 2026 12:38:05 +0000 https://cluster-site.onrender.com/posts/first-ever-inhalable-gene-therapy-for-cancer-gets-fast-tracked-by-fda/ • The gene therapy is administered as a mist that is inhaledNico De Pasquale Photography/Getty Images The gene therapy is administered as a mist that is inhaled Nico De Pasquale Ph