Wednesday, November 11, 2026
Via News Knowledge File

U.S. Food and Drug Administration

government agency80% conf.·synced Nov 11, 2026

U.S. federal agency responsible for regulating drugs and medical devices

59
sourced metrics
3242
relationships
20
stated objectives
0
Via News reports

Every fact below is drawn from Via News's knowledge graph and linked to the source document it came from. Nothing here is unsourced. How we source →

Key metrics · each point sourced

Parameter Count
6months_priority_review
Jun 15, 2026source
Ai Devices Cleared
1350devices
Feb 3, 2026source
Drug Approvals
17drugs
Jan 20, 2026⚠ sources conflictsource
Approval Decisions
32decisions
Jan 20, 2026source
Ai Device Authorizations
250devices
Sep 1, 2025source
Total Ai Devices Authorized
1247count
Jun 30, 2025source
Cardiology Ai Algorithms Total
116algorithms
May 1, 2025source
Ai Algorithms Cleared May 2025
39algorithms
May 1, 2025source
Accelerated Approvals
11drugs
Jan 1, 2025source
Approved Car T Products
7products
Jan 1, 2025source
Approved Gene Therapies Global
36products
Jan 1, 2025source
Approved Non Modified Cell Therapies
71products
Jan 1, 2025source
Biologics Approved
12biologics
Jan 1, 2025source
Fast Track Designations
18drugs
Jan 1, 2025source
First In Class Drugs
20drugs
Jan 1, 2025source
New Molecular Entities Approved
34NMEs
Jan 1, 2025source
Novel Drugs Approved
46drugs
Jan 1, 2025source
Oncology Approvals
50treatments
Jan 1, 2025source

Stated objectives

Evaluate appropriate regulatory pathway for CBD products beyond existing food and dietary supplement frameworks

source
stated

Reduce lead in fruit-based baby foods

source
target: 10 ppb by 2025-01-01 00:00:00stated

Reduce lead in root vegetables and dry infant cereals

source
target: 20 ppb by 2025-01-01 00:00:00stated

Complete regulatory review of TransCon CNP with PDUFA target action date

source
by 2026-02-28 00:00:00stated

FDA supports AI-based medical devices and healthcare digitization programs to accelerate AI integration in U.S. healthcare

source
stated

FDA aims to accelerate regenerative medicine advancement through expedited approval pathways while maintaining rigorous safety and efficacy standards

source
stated

Speed up the development of safe, effective, and innovative medical devices critical to public health through the TPLC Advisory Program Pilot

source
stated

Review CagriSema regulatory application for weight management

source
by 2026-01-01 00:00:00stated

Expedite development and review timelines of drugs that demonstrate potential to treat serious conditions through Fast Track designation program

source
stated

Set daily sodium intake target for food categories including salad dressings

source
target: 2750 mg daily, 220 mg per serving for salad dressings by 2025-01-01 00:00:00stated

Relationship graph · 3242 connections

regulates
2737
regulated by
310
approved by
65
located in
34
governs
21
subsidiary of
13
regulated
12
approved
9
This Knowledge File is assembled from Via News's source-traceable knowledge graph. Metrics, objectives and relationships are extracted from primary and credible secondary documents and refreshed on a schedule. Read our methodology →
What we know · the intelligence behind this page
Live from the substrate
What we're seeing
Biotech Catalyst Wave: Late-2026 Clinical Readouts, PDUFA Dates and Capital Restructuring
A dense cluster of Q4 2026 to Q1 2027 clinical and regulatory catalysts spans hepatitis delta (Vir's ECLIPSE/SOLSTICE), hypertension and sleep apnea (Mineralys' lorundrostat, PDUFA 2026-12-22), severe hypertriglyceridemia (plozasiran), oncology (ivonescimab BLA, PDUFA 2026-11-14) and gene therapy (Krystal). Positive data flow from AASLD and AHA presentations is offset by cost-cutting guidance, milestones slipping into 2027, and a delisting process that signals capital-market stress for some issuers. Near-term value hinges on binary FDA decisions and Phase 3 topline readouts in Q1 2027.
Our read on the data ›
Signals we're tracking
EPKINLY Regulatory-Clinical Success Cascade
High probability of expanded label indications, additional combination approvals, and competitive positioning strength in follicular lymphoma market. Predicts positive commercial uptake and potential accelerated review for related indications.
Patterns we're watching ›
Where sources disagree
Ford Motor Company
Both facts give cash for Ford Motor Company at the same point in time (2025-12-31; FY 2025 year-end and Q4 2025 year-end are the same date). Both are labelled USD, but the values are 23,356,000,000 and 23.356, which cannot both be true in USD. The two numbers agree once the second is read as billions (23.356 bn = 23,356,000,000), so the economic content is consistent and the conflict is a unit/scale error in the Q4 2025 record. The period is not the reason for the conflict: a Q4 and an FY figure at the same year-end date should match.
We flag conflicts openly ›
Recently verified
✓ Checked against the original source
4,995
facts traced to their source — and we flag the ones that don't hold up.
101 entities tracked4,995 facts checked against source5,564 source documents archived
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