🚫Amylyx Pharmaceuticals' RELYVRIO Drug Approval Withdrawn by FDA
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for RELYVRIO (sodium phenylbutyrate and taurursodiol) for suspension, 3 gram (g)/ packet and 1 g/packet, held by Amylyx Pharmaceuticals, Inc. (Amylyx), 43 Thorndike St., Cambridge, MA 02141. Amylyx has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Learn More⚡NedPower Mount Storm Section 206 Compliance Notice Overview
The Federal Energy Regulatory Commission has initiated a proceeding to investigate whether NedPower Mount Storm LLC's Rate Schedule is unjust or unlawful, establishing a refund effective date based on this notice. Interested parties have a 21-day window to intervene, highlighting the importance of compliance and the potential for regulatory changes in the energy market.
Learn More🏗️Antidumping Duties on Corrosion-Resistant Steel Products from Vietnam
The U.S. Department of Commerce (Commerce) determines that certain corrosion-resistant steel products (CORE) from the Socialist Republic of Vietnam (Vietnam) are being, or are likely to be, sold in the United States at less than fair value (LTFV) for the period of investigation (POI) January 1, 2024, through June 30, 2024.
Learn More📄Analysis of SSA's Information Collection and Its Business Implications
The Social Security Administration has proposed revisions to information collection requirements related to various forms that impact benefits and compliance. These changes address the accuracy and burden estimates associated with collecting data from beneficiaries and other respondents, highlighting the need for public comments on proposed information collections.
Learn More⚡Combined Notice of Electric Corporate Filings and Authorizations
The Department of Energy announces several electric corporate filings received by the Federal Energy Regulatory Commission. The document details various applicants and their applications for authorizations under the Federal Power Act, highlighting deadlines for comments and interventions in ongoing regulatory processes.
Learn More⚛️NRC Considers License Renewal for Crow Butte Resources
The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the renewal of Source and Byproduct Materials License Number SUA-1534, which authorizes Crow Butte Resources, Inc., to operate the existing Crow Butte Project in-situ uranium recovery facility and to construct and operate the Marsland Expansion Area.
Learn More🐅Emergency Permit Issued for Import of Endangered Species
We, the U.S. Fish and Wildlife Service, have waived the 30-day public notice period and have issued an endangered species permit for import of five tigers (Panthera tigris). We issue this permit under the Endangered Species Act and the Convention on International Trade in Endangered Species of Wild Fauna and Flora.
Learn More📜FERC Notice on Off-the-Record Communications and Compliance
The Department of Energy's notice clarifies the handling of off-the-record communications relevant to contested proceedings before the FERC. It outlines the requirements for Commission employees to report such communications and their implications for the decisional records of cases, impacting transparency and fairness in regulatory processes.
Learn More🏥Withdrawal of CMS Data Collection Comment Requests
On Tuesday, August 5, 2025, the Centers for Medicare & Medicaid Services (CMS) published a notice document entitled, "Agency Information Collection Activities: Proposed Collection; Comment Request". That notice invited public comments on five separate information collection requests, under Document Identifiers: CMS-10495, CMS 855S and CMS-R-131. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled, "Data Collection and Submission for Open Payments" Form number: CMS-10495 (OMB control number: 0938-1237). We are also withdrawing the portion of the notice requesting public comment on the information collection titled, "Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers." Form number: CMS-855S (OMB control number: 0938-1056.
Learn More🐟New England Fishery Management Council Public Meeting Notice
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scallop Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
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