Fda | Tenu Tech Brief

FDA does U-turn, will review Moderna's 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

FDA reverses surprise rejection of Moderna's 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

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. •

Ocular Therapeutix Eyes FDA Filing After Wet AMD Drug Tops Regeneron's 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. •

What the FDA's 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

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. •

What the FDA's 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

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

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