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Food and Drug Administration

The FDA is the U.S. federal agency that regulates drugs, vaccines, medical devices, and food safety, overseeing clinical trials and public health standards.

Known aliases

  • Food and Drug Administration

Current stories

leadershipConfirmed2 publishers

HHS sends the White House a peptide access policy for specialty pharmacies

HHS has sent the White House budget office an interim access policy on peptides, according to a posting on a government website. Two people familiar with the plan say it would assure pharmacies they will not be targeted for making certain peptides.

Perspective Coverage

3 publishers
Builder
Builder 10%
Operator
Operator 67%
Investor
Investor 23%

Reality

Evidence50
Adoption
Not scored
Hype gap+20
Incentives75
Confidence55
scienceOne report1 publisher

Celiac patients given FB102 kept more intestinal lining under gluten challenge, argenx reports

argenx says its intravenous drug FB102 preserved more intestinal lining than placebo in a 126-patient phase 2 celiac disease trial. The readout is topline and not yet peer-reviewed, and ScienceAlert's report does not say how large the difference was.

Publishers:sciencealert.com

Reality

Evidence35
Adoption
Not scored
Hype gap+20
Incentives70
Confidence55
scienceOne report1 publisher

MIT students' 2017 tremor wristband wins FDA clearance nine years on

Encora Therapeutics won FDA clearance in February for a tremor wristband that MIT students first built in a 2017 class. The cleared use is adults with essential tremor, and in one trial 78 percent of patients reported benefit after 90 days of home use.

Publishers:news.mit.edu

Reality

Evidence40
Adoption
Not scored
Hype gap+15
Incentives65
Confidence45
investOne report1 publisher

Semafor reports FDA nominee Overton helped craft the case for cutting recommended childhood vaccines to 11

Heidi Overton, Trump's FDA nominee, helped craft the justification for cutting CDC-recommended childhood vaccines from 17 to 11, Semafor reported. The Senate health committee left without voting on her nomination, so confirmation falls to the lame-duck session.

Publishers:semafor.com

Reality

Evidence40
Adoption
Not scored
Hype gap
Not scored
Incentives60
Confidence45
scienceOne report1 publisher

Rep. Auchincloss plans a bill to copy Australia's faster early-phase trial rules

Rep. Jake Auchincloss (D-Mass.) plans a bill modelled on Australia's faster early-phase clinical trial regime, he said at the STAT Summit. He wants the US to answer China's biotech rise by speeding domestic research.

Publishers:statnews.com

Reality

Evidence35
Adoption
Not scored
Hype gap+10
Incentives50
Confidence55
investConfirmed2 publishers

First new US sunscreen filter in 25 years reaches shelves in Neutrogena formulas

Neutrogena and other makers are selling sunscreens with bemotrizinol, the first new US filter in over 25 years, after FDA approval in June. Dermatologists see a technical edge. No prices or sales figures have been published yet.

Perspective Coverage

3 publishers
Builder
Builder 10%
Operator
Operator 53%
Investor
Investor 37%

Reality

Evidence78
Adoption20
Hype gap+8
Incentives35
Confidence75
scienceOne report1 publisher

Off-label testosterone prescriptions for US women rose 58.7% in 2025 to over 90,000

A 2026 US study recorded more than 90,000 off-label testosterone prescriptions to women in 2025, up 58.7% from 2024. The FDA has not approved the hormone for menopause, and the only positive trial signal described is for low sexual desire.

Publishers:livescience.com

Reality

Evidence55
Adoption50
Hype gap+40
Incentives
Not scored
Confidence60
scienceOne report1 publisher

Compass Pathways CEO wants a slow COMP360 launch to protect the psychedelics field

Compass Pathways expects to complete its rolling FDA submission for COMP360 this quarter and launch early next year, CEO Kabir Nath said. He wants a slow, provider-trained rollout under an expected REMS, because early bad experiences could damage the broader sector.

Publishers:statnews.com

Reality

Evidence50
Adoption
Not scored
Hype gap+10
Incentives60
Confidence55
scienceOne report1 publisher

Three former FDA chiefs say DOGE and Makary-era exits cost the agency knowledge it will take years to restore

Three former FDA chiefs said DOGE's 3,500 job cuts and a larger exodus under Marty Makary cost the agency institutional knowledge. Ned Sharpless said companies he works with now meet more junior reviewers.

Publishers:statnews.com

Reality

Evidence40
Adoption
Not scored
Hype gap+30
Incentives
Not scored
Confidence50
scienceOne report1 publisher

Whoop gets full Medicare payment only if patients' blood pressure, A1C and LDL improve or stay controlled

Whoop, accepted into Medicare's ACCESS program, must show better or controlled blood pressure, A1C and LDL cholesterol to be paid in full. Chief medical officer Ami Bhatt told the STAT Summit that simplifying the app comes first for patients 65 and older.

Publishers:statnews.com

Reality

Evidence40
Adoption15
Hype gap+20
Incentives60
Confidence55
leadershipOne report1 publisher

GLP-1 drugs outsold generative AI in 2025 on Exponential View's own estimate of AI revenue

Exponential View says GLP-1 sales reached $76 billion in 2025, ahead of its own $63 billion estimate for generative AI. The $13 billion lead rests on that estimate, and the retention studies the piece cites show heavy attrition.

Reality

Evidence45
Adoption11
Hype gap+20
Incentives40
Confidence50
investOne report1 publisher

Gallup's revised survey finds 11% of US adults taking GLP-1s for weight loss, up from 3% in 2024

Gallup found 11% of US adults now take a GLP-1 for weight loss, up from 3% in 2024. Its survey of 5,065 adults counts users, not spending, so food and insurance planners still need their own dollar figures.

Publishers:news.gallup.com

Reality

Evidence62
Adoption11
Hype gap+10
Incentives
Not scored
Confidence66
productConfirmed3 publishers

Pixel Watch 5 costs $50 more for health features that ship next month, or later

Blood pressure, insulin-resistance and sleep-breathing metrics are not in the box, and breathing-emergency detection awaits FDA clearance. The Verge is publishing its review in parts.

Perspective Coverage

3 publishers
Builder
Builder 22%
Operator
Operator 60%
Investor
Investor 18%

Reality

Evidence70
Adoption
Not scored
Hype gap+20
Incentives45
Confidence72
leadershipOne report1 publisher

FDA's unannounced chatbot session gave select tech firms an early say in health-AI guidance

FDA officials hosted at least 35 industry groups at an unannounced February session on patient chatbots, after inviting them in a CMS Slack chat room. The guidance it informs will cover every patient-chatbot maker, including firms left outside the room.

Publishers:cbsnews.com

Reality

Evidence62
Adoption20
Hype gap+30
Incentives75
Confidence58
scienceOne report1 publisher

FDA ties any mifepristone restrictions to a safety report due by March 2027

FDA's court-ordered filing schedules a mifepristone safety report for no later than March 2027, ahead of any decision on new restrictions. Abortion opponents hoping to curtail the pill's use quickly condemned a timeline that keeps the review running into 2027.

Publishers:statnews.com

Reality

Evidence58
Adoption
Not scored
Hype gap0
Incentives62
Confidence60
scienceConfirmed3 publishers

Vaxcyte says its 31-strain pneumococcal shot met Phase 3 goals against Prevnar and Capvaxive

Vaxcyte said its 31-strain pneumococcal vaccine hit its primary Phase 3 endpoints in a trial against Pfizer's 20-strain and Merck's 21-strain shots. The trial compared antibody levels, so the strain-by-strain results will decide how far the extra coverage threatens the two incumbents.

Perspective Coverage

3 publishers
Builder
Builder 30%
Operator
Operator 15%
Investor
Investor 55%

Reality

Evidence50
Adoption3
Hype gap+30
Incentives70
Confidence60
investOne report1 publisher

Cigarettes are the second most popular way to quit vaping in an ASH survey of UK adults

Action on Smoking and Health surveys found 19% of 940 UK adults, and 14% of a New Zealand sample, used cigarettes to try to quit vaping. Both figures count quit attempts and leave open how many people stayed on cigarettes.

Publishers:fortune.com

Reality

Evidence45
Adoption
Not scored
Hype gap+35
Incentives55
Confidence45
scienceOne report1 publisher

DEA's 7-OH proposal would leave natural kratom largely unregulated

DEA proposed in July to temporarily place 7-OH above a potency threshold in Schedule I, and nearly 36,000 public comments came in by Sept. 10. Experts agree kratom needs guardrails but split on where the line belongs.

Publishers:statnews.com

Reality

Evidence62
Adoption
Not scored
Hype gap+10
Incentives60
Confidence55
leadershipOne report1 publisher

Kennedy wants AI to search Americans' linked health records, including for vaccine outcomes

HHS chief Robert F Kennedy Jr wants health data linked and AI-searchable to study vaccines and chronic disease, citing Medicaid's tens of millions of children. For private holders of health data, the routes he described run through patient apps, commercial linkers and state reporting.

Publishers:theguardian.com

Reality

Evidence35
Adoption30
Hype gap+45
Incentives65
Confidence40

Earlier coverage

  1. Moderna's per-patient cancer vaccine cleared Phase 3. Now it is a manufacturing problem.

    Product · August 20, 2026 · Confirmed3 publishers

  2. CDC's measles counter shows one death as Pennsylvania officials report four

    Science · September 24, 2026 · Confirmed2 publishers

  3. Meta puts its FDA-cleared hearing aid behind a one-time $149.99 unlock

    Product · September 23, 2026 · Confirmed3 publishers

  4. A three-marker blood test flagged 87% of stage 1 and 2 pancreatic cancers in 1,800 patients

    Science · September 16, 2026 · Confirmed2 publishers

  5. Bodega peptides fail their own label test at about $94 a vial

    Product · September 15, 2026 · One report1 publisher

  6. Orexin's discoverers win the Lasker basic-science award a month after the first agonist approval

    Science · September 10, 2026 · Confirmed2 publishers

  7. Migraine prevention guidelines elevate CGRP drugs after a 14-year gap

    Science · August 31, 2026 · Confirmed2 publishers

  8. The next DSM will name biology it cannot yet measure

    Science · August 26, 2026 · One report1 publisher