# Medicines and Healthcare products Regulatory Agency

Type: Company

Source: GetYourBrief — https://getyourbrief.com/entity/medicines-and-healthcare-products-regulatory-agency
Canonical HTML page: https://getyourbrief.com/entity/medicines-and-healthcare-products-regulatory-agency

## Timeline

- **2026-09**: Interim 3-year overall survival data expected — Company expects to announce interim 3-year overall survival data from the Phase 2b OST-HER2 trial in early September 2026.
- **2026-09**: FDA Type C Statistical Methods Meeting — Meeting expected in mid-September 2026 with CBER to review statistical methods, comparator appropriateness, RMAT designation, and rolling review.
- **2026-09**: MHRA Scientific Advice Meeting — UK MHRA meeting expected in September 2026 to review statistical methods supporting the CMAA, including finalization with 2.5-year overall survival.
- **2026-09**: Interim 3-year overall survival data expected — Company expects to announce interim 3-year overall survival data from the Phase 2b OST-HER2 trial in early September 2026.
- **2026-09**: FDA Type C Statistical Methods Meeting — Meeting expected in mid-September 2026 with CBER to review statistical methods, comparator appropriateness, RMAT designation, and rolling review.
- **2026-09**: MHRA Scientific Advice Meeting — UK MHRA meeting expected in September 2026 to review statistical methods supporting the CMAA, including finalization with 2.5-year overall survival.
- **2026-08-13**: Company announces FDA Type C meeting and MHRA parallel review — OS Therapies announces FDA granted Type C Statistical Methods Meeting to review 2.5-year OS data for OST-HER2; MHRA Scientific Advice Meeting granted in parallel.
- **2026-08-13**: Company announces FDA Type C meeting and MHRA parallel review — OS Therapies announces FDA granted Type C Statistical Methods Meeting to review 2.5-year OS data for OST-HER2; MHRA Scientific Advice Meeting granted in parallel.

## Recent coverage (3 stories, network-wide)

### FDA Type C Meeting to Review 2.5-Year OS Data in Osteosarcoma
2026-08-14 01:42:06 · Sector: health · Sentiment: Positive · Impact: 7/10 · Sources: 2

For healthcare regulators and health systems, OS Therapies' FDA Type C meeting on OST-HER2 will test whether historical control data can support approval in rare osteosarcoma. With MHRA running parallel advice and a biomarker qualification review pending, the case could reshape evidence standards in ultra-rare cancers.
Full story: https://gethealthbrief.com/story/fda-type-c-meeting-ost-her2-health

### OST-HER2 2.5-Year OS Data Drives FDA Type C Meeting
2026-08-14 01:41:55 · Sector: bio · Sentiment: Positive · Impact: 7/10 · Sources: 2

Biotech stakeholders are watching OST-HER2's FDA Type C meeting because the statistical comparator decision could de-risk or delay a rare oncology asset. With 3-year survival data due days earlier and MHRA engagement in parallel, the event sequence is a near-term catalyst.
Full story: https://getbiobrief.com/story/ost-her2-fda-type-c-meeting-bio

### India-UK FTA Drives $981M Pharma Export Target, 8.66% Jump by FY27
2026-07-27 10:10:49 · Sector: bio · Sentiment: Positive · Impact: 6/10 · Sources: 2

The zero-tariff India-UK trade pact propels Indian pharmaceutical exports to a projected $981M, offering biotech and pharma firms expanded market access, lower costs, and new collaboration channels in R&D and manufacturing.
Full story: https://getbiobrief.com/story/india-uk-fta-pharma-exports-981-million-fy27

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