Business · 19/12/2025Updated: 10/17/2026 · 1 min read

FDA Awards Priority Review Voucher to FORZINITY Sponsor

Summary

The FDA has issued a priority review voucher to Stealth BioTherapeutics Inc. for its rare pediatric disease product FORZINITY (elamipretide), approved on September 19, 2025.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

Add your company to Business Communicator

We monitor business sources and connect attention with companies, profiles and services available in Business Communicator.

Create a free company profile Explore businesses on Business Maps →

Create a free company profile →

Explore insights

Business insights →

Healthcare Business News Global Markets News Trade Regulation News Business Technology News Fintech for Business: Payments & Banking News Supply Chain News

Related business signals

Business · 9/16/2026

Food and Drug Administration Announces Proposed Collection of Information for Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Read summary →

Business · 9/16/2026

Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists

The Centers for Disease Control and Prevention (CDC) issued an Order under Sections 362 and 365 of the Public Health Service Act, continuing the suspension of introducing certain persons from countries with a quarantinable communicable disease outbreak.

Read summary →

Business · 9/15/2026

FDA Establishes Public Docket for Rare Disease Clinical Investigations Statistical Considerations

The FDA is collecting feedback on statistical considerations for rare disease clinical investigations through a public docket, which is open until a certain date, and a Rare Disease Innovation, Science, and Exploration (RISE) Workshop on the topic.

Read summary →

Business · 10/9/2026

Center for Scientific Review Notice of Closed Meetings

The Center for Scientific Review has announced closed meetings for the following review groups: the Neurological Sciences A Study Section and the Neurological Sciences B Study Section.

Read summary →

Business · 10/5/2026

CDC Invites Public Comment on Proposed Data Collection for Public Health Crisis Response

The Centers for Disease Control and Prevention (CDC) is seeking public feedback on a proposed data collection project, titled Public Health Crisis Response (PHCR) Cooperative Agreement, which aims to rapidly fund public health programs responding to major emergencies and crises, as required by the Paperwork Reduction Act of 1995.

Read summary →

Business · 10/5/2026

CDC Requests Public Comment on Respiratory Protective Devices Data Collection

The Centers for Disease Control and Prevention (CDC) is seeking public input on a proposed data collection project related to Respiratory Protective Devices, as required by the Paperwork Reduction Act of 1995, to inform the approval certification activities under 42 CFR part 84.

Read summary →