FDA

Health & Wellness 4 min The FDA Approved a Heart Valve That Doctors Can Widen as a Child Grows The Autus device starts at about 13 mm and is stretched with a balloon catheter to as much as 22 mm, sparing s... AM Amelia Wong 2 Oct Health & Wellness 4 min The First Approved Drug for MCT8 Deficiency Treats the Body's Excess Hormone, Not the Brain The FDA approved Egetis's Emcitate (tiratricol) on 28 September. It lowers the thyroid hormone that builds up... AM Amelia Wong 30 Sep Health & Wellness 3 min Tavapadon, a Parkinson's Drug Aimed at Different Dopamine Receptors, Wins FDA Approval AbbVie's Juvmo, tavapadon, is the first to target D1 and D5 receptors. It beat placebo in three trials but was... AM Amelia Wong 29 Sep Health & Wellness 4 min The FDA Approved a Once-a-Week Insulin for Type 2 Diabetes Lilly's Onswik lowered blood sugar about as well as daily insulin in four trials. It is not recommended for ty... AM Amelia Wong 28 Sep Health & Wellness 4 min The FDA Approved a Third Drug for a Disease That Turns Muscle Into Bone Atebrioz joins two earlier treatments for fibrodysplasia ossificans progressiva, one approved five weeks ago.... AM Amelia Wong 27 Sep Health & Wellness 7 min Four AI Devices Reach Medicare Patients Without Clearance, or a Review Board The FDA's TEMPO pilot sets aside more than marketing authorisation. Enforcement discretion also covers the IDE... AM Amelia Wong 3 Sep Health & Wellness 6 min The Cancer Blood Test Going to the FDA Missed Its Primary Endpoint GRAIL's test goes to an FDA advisory committee on 23 September, the first of its kind to get there. The trial... AM Amelia Wong 31 Aug Health & Wellness 6 min J&J Says the FDA Authorised Its OTTAVA Surgical Robot — Almost Nothing in the Announcement Can Be Checked Yet The release never says "nine procedures". Both performance claims cite unpublished internal documentation. And... AM Amelia Wong 26 Jul Health & Wellness 9 min The FDA Is Reviewing 7 Peptides on 23–24 July — Here's What That Does and Doesn't Mean The FDA's Pharmacy Compounding Advisory Committee will review seven peptides — BPC-157, KPV, TB-500, MOTS-c, E... AM Amelia Wong 9 Jul Health & Wellness 8 min Researchers Push Back on the FDA's 2026 Wellness-Device Guidance — What It Means for Wearable Owners A Nature Biomedical Engineering Comment published on 23 June 2026 argues that the FDA's 2026 General Wellness... AM Amelia Wong 2 Jul Health & Wellness 5 min The FDA wants clinical trials to report in real time, with AI doing the watching The US Food and Drug Administration has started two pilot trials that send their results to the agency as the... AM Amelia Wong 2 Jun