# U.S. Food and Drug Administration (FDA)

Type: regulator

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/us-food-and-drug-administration-fda-regulator
Canonical HTML page: https://getbiobrief.com/entity/us-food-and-drug-administration-fda-regulator

## Timeline

- **2024-06**: SCOTUS Ruling — Supreme Court preserves access to mifepristone by ruling plaintiffs lacked standing in FDA challenge.
- **2022-06**: Dobbs Decision — SCOTUS overturns Roe v. Wade, triggering state-level bans and increasing demand for pills.
- **2021-12**: Telehealth Shift — FDA permanently removes the requirement that mifepristone be dispensed in person.
- **2016-03**: Label Update — FDA expands usage to 70 days gestation and reduces required office visits.
- **2000-09**: FDA Approval — FDA approves Mifeprex (mifepristone) for medical termination of pregnancy.

## Recent coverage (3 stories)

### Vera’s TRUTAKNA Gets FDA Nod with 42% UPCR Reduction, Awaits Kidney Data
2026-07-12 07:11:54 · Sentiment: Bullish · Impact: 8/10 · Sources: 2

Vera Therapeutics scores an accelerated approval for TRUTAKNA in IgA nephropathy, touting a 42% UPCR reduction vs placebo in Phase 3 ORIGIN 3. The dual BAFF/APRIL inhibitor enters a competitive market with a surrogate endpoint—investors await the confirmatory eGFR data.
Full story: https://getbiobrief.com/story/vera-trutakna-fda-accelerated-approval-iga-nephropathy

### FDA Creates New Product Code for Solius Pro UVB Device, Cutting UV Risk 99%
2026-06-18 01:32:38 · Sentiment: Bullish · Impact: 7/10 · Sources: 2

The FDA has established a novel product code for Solius Pro, an over-the-counter UVB light therapy device that claims to deliver biological benefits of sunlight with dramatically reduced risk. The move signals regulatory recognition of personalized home phototherapy as a distinct category.
Full story: https://getbiobrief.com/story/fda-new-product-code-solius-pro-uvb-99-risk-reduction

### Medication Abortion Dominates US Market Amid Escalating Regulatory Warfare
2026-03-24 07:47:20 · Sentiment: Neutral · Impact: 7/10 · Sources: 2

Medication abortion has surged to account for the majority of pregnancy terminations in the U.S., driven by telehealth expansion and mail-order access. This shift has catalyzed a sophisticated legal and legislative counter-offensive aimed at the FDA's regulatory authority and the distribution of pharmaceutical products.
Full story: https://getbiobrief.com/story/medication-abortion-market-trends-2026

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This page is a machine-readable summary. Sentiment measures the directional read of each development for this entity, not the tone of the reporting; impact weights consequence, not syndication reach. See https://getbiobrief.com/guides/methodology for the full editorial methodology.