What are regulators doing right now that matters to our portfolio?
Recent regulatory signals
Latest regulatory-related signals across the portfolio.
| Signal | Agency | Therapeutic area | Date |
|---|---|---|---|
| FDA Accepts Supplement Application for Tyvaso (Treprostinil) FDA · Pulmonary Arterial Hypertension · Prostacyclin Analog | FDA | Pulmonary Arterial Hypertension · Prostacyclin Analog | Jun 6, 2026 |
| FDA Submission for Dapagliflozin by Jiangsu Hansoh Pharma FDA · Diabetes · SGLT2 Inhibitor | FDA | Diabetes · SGLT2 Inhibitor | Jun 6, 2026 |
| Enhertu recommended for EU approval in HER2+ metastatic solid tumours AstraZeneca · Oncology · HER2-positive solid tumours | AstraZeneca | Oncology · HER2-positive solid tumours | Jun 2, 2026 |
| Zhuochuming® Trial Evaluates 3+T&E vs 3+PRN in Diabetic Macular Edema EMA · Ophthalmology · Diabetic Macular Edema | EMA | Ophthalmology · Diabetic Macular Edema | Jun 1, 2026 |
| FDA Issues Guidance on Postapproval Pregnancy Safety Studies FDA · General · Drug Safety | FDA | General · Drug Safety | Jun 1, 2026 |
| AstraZeneca's Baxfendy Receives US Approval for Hypertension as First-in-Class Treatment AstraZeneca · Cardiology · Hypertension | AstraZeneca | Cardiology · Hypertension | Jun 1, 2026 |
| Breztri Gains US Approval as First Triple Therapy for Asthma AstraZeneca · Respiratory · Asthma | AstraZeneca | Respiratory · Asthma | Jun 1, 2026 |
High impact regulatory events
Top regulatory signals ranked by importance and confidence.
FDA Accepts Supplement Application for Tyvaso (Treprostinil)
FDA · Pulmonary Arterial Hypertension · Prostacyclin Analog
FDA Submission for Dapagliflozin by Jiangsu Hansoh Pharma
FDA · Diabetes · SGLT2 Inhibitor
Enhertu recommended for EU approval in HER2+ metastatic solid tumours
AstraZeneca · Oncology · HER2-positive solid tumours
Regulatory activity feed
FDA, EMA, MHRA, and PMDA activity grouped chronologically.
FDA
FeedFDA AP — BAXFENDY (ORIG)
Jun 6, 2026Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as United Therapeutics; the same agency is already in play for this signal, so precedent weight is higher.
FDA AP — TYVASO (SUPPL)
Jun 6, 2026Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as United Therapeutics; the same agency is already in play for this signal, so precedent weight is higher.
FDA Accepts Supplement Application for Tyvaso (Treprostinil)
Jun 6, 2026The FDA has accepted a supplemental application for Tyvaso, an inhaled formulation of treprostinil.
Top regulatory precedents
Regunera precedents with confidence, pathway, and why this matters.
- FDAsafety guidance95% confidence
Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
Why relevant: Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Source - FDAsafety guidance95% confidence
Newly Added Guidance Documents
Why relevant: Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Source - FDAsafety guidance95% confidence
Recently Issued Guidance Documents
Why relevant: Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Source - FDAsafety guidance84% confidence
Drugs@FDA Data Files
Why relevant: Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Source - FDAsafety guidance84% confidence
Novel Drug Approvals for 2026
Why relevant: Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Source - FDAsafety guidance83% confidence
Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
Why relevant: Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Comparative Study of SPSIPB vs Thoracic Paravertebral Block for Opioid Reduction.
Source - FDAsafety guidance83% confidence
Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
Why relevant: Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Comparative Study of SPSIPB vs Thoracic Paravertebral Block for Opioid Reduction.
Source - PMDAsafety guidance83% confidence
[SHINSA]List of therapeutic products for which eligible patients can be identified by Drug-Agnostic CDx,posted
Why relevant: Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Study on NMES for Functional Recovery in COPD and Pneumonia Patients.
Source