The HCPFive: Top News for Healthcare Providers from the Week of 05/10

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know — whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include FDA submissions for mitapivat in sickle cell disease and encaleret in autosomal dominant hypocalcemia type 1 (ADH1), the resignation of FDA Commissioner Marty Makary, MD, MPH, the FDA clearance of the EndoTool IV Cloud, and new American Heart Association guidelines for optimizing postpartum heart health in women.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of May 10, 2026 — let's jump in!

Mitapivat sNDA Seeks FDA Accelerated Approval in Sickle Cell Disease

On May 12, 2026, Agios submitted a Supplemental New Drug Application (sNDA) to the FDA seeking accelerated approval of mitapivat for sickle cell disease. The filing, which was supported by data from the RISE UP phase 2 and phase 3 programs, places the oral pyruvate kinase activator under FDA review for a potential new hematology indication after prior approvals in other rare hemolytic anemias.

BridgeBio Submits NDA for Encaleret for Autosomal Dominant Hypocalcemia Type 1

On May 12, 2026, BridgeBio submitted a NDA for encaleret to the FDA for patients with ADH1. The submission follows positive results from the CALIBRATE phase 3 trial, in which encaleret achieved all pre-specified primary and key secondary efficacy endpoints. The company is currently enrolling patients in CALIBRATE-PEDS, a global registrational phase 2/3 study of encaleret in pediatric ADH1.

FDA Commissioner Marty Makary Resigns, Kyle Diamantas Steps In as Acting Head

On May 12, 2026, FDA Commissioner Marty Makary, MD, MPH, resigned from his position following weeks of reports that the Trump administration was planning his removal. Kyle Diamantas, JD, the Agency's Deputy Commissioner for Food, has been named acting commissioner while a permanent replacement is identified. The resignation marks one of the fastest commissioner departures in modern FDA history. Makary served in the role for just over a year, having been confirmed on March 25, 2025, by a bipartisan vote of the US Senate as the 27th Commissioner of Food and Drugs.

FDA Clears EndoTool IV Cloud for Inpatient IV Insulin Dosing Support

On May 14, 2026, the FDA cleared the EndoTool IV Cloud, a cloud-based version of parent company Glooko’s inpatient intravenous insulin dosing decision-support platform, through the 510(k) pathway. According to the company, the newly cleared product uses the same insulin-dosing algorithm as the existing EndoTool IV system and is expected to launch commercially in the US before the end of 2026.

New AHA Recommendations Encourage Improving Postpartum Cardiovascular Care

A recent publication from the American Heart Association has provided a set of guidelines and tools to optimize postpartum heart health for women. The recommendations aim to provide a pathway for evidence-based care implementation during the postpartum phase, which has been historically overlooked in its potential for cardiovascular risk.

The document is its second iteration following a secondary literature review and ongoing dialogue with clinical and community organizations. The recommendations are collected into 4 major points: standardizing postpartum systems, interdisciplinary care and engagement, advocacy and policy expansion, and risk factor identification and monitoring.