Thursday, October 15, 2026
Via News Knowledge File

U.S. Food and Drug Administration

government agency80% conf.·synced Oct 14, 2026

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

59
sourced metrics
3213
relationships
20
stated objectives
1
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 · 3213 connections

regulates
2708
regulated by
310
approved by
65
located in
34
governs
21
subsidiary of
13
regulated
12
approved
9

Via News coverage

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
Q4 2026 Clinical Catalyst Season: Big-Pharma Data Flow, Regulatory Milestones, and a Thin AI-Drug Fringe
October 2026 conferences (EASD, IGCS, NACFC, HFSA) are producing a dense run of late-stage readouts from Novo Nordisk, Lilly, Roche, Bayer, Vertex and Galderma. Regulatory milestones are scheduled behind them: the ivonescimab BLA PDUFA date on 2026-11-14, FDA acceptance of Roche's vamikibart BLA, and Scholar Rock's EMA resubmission. The AI-and-finance angle is peripheral. It consists of the AI-designed drug Rentosertib and QAIAx, a speculative microcap whose trial claims (the QIII pilot, anticipated 2027-01-01, and a patent update) are forecasts and filings rather than data, so they warrant skepticism.
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
ING Group
Both facts record the same metric (shares_outstanding) for ING Group at the identical observation date (2025-12-31). FACT A states 2,902,437,688 shares; FACT B states 2,902 million shares (2,902,000,000). The difference is 437,688 shares (~0.015%). This is a genuine value conflict, though the discrepancy appears to result from FACT B rounding to the nearest million while FACT A provides the precise count.
We flag conflicts openly ›
Recently verified
✓ Checked against the original source
4,986
facts traced to their source — and we flag the ones that don't hold up.
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