Search Results for keywords:"accelerated approval"

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.” This guidance is aimed at describing how the FDA interprets the term "underway" in relation to confirmatory drug trials required after a drug has been granted accelerated approval. These trials are crucial for verifying the drug's effects on serious health conditions. The FDA is inviting the public to comment on this draft guidance by March 10, 2025, as part of their ongoing approval process requirements.

The Food and Drug Administration (FDA) has released draft guidance to accelerate the approval process for drugs and biologics meant for serious or life-threatening conditions. This expedited program aims to quickly develop and review drugs that address unmet medical needs. The draft outlines the criteria for accelerated approval, including surrogate endpoints and confirmatory trials, and introduces procedures for rapidly withdrawing approvals if necessary. The public can submit comments on this draft by February 4, 2025, and share thoughts on the expedited withdrawal procedures and other aspects of the accelerated approval process.

The Securities and Exchange Commission has approved a proposed rule change from the Options Clearing Corporation (OCC) to enhance its stress testing scenarios. The OCC aims to elevate four existing Informational Scenarios to Sufficiency Scenarios, which will more rigorously test whether it has enough financial resources to cover potential losses during extreme market conditions. This change comes in response to market events observed in March 2020, including extreme price changes, and aims to ensure OCC can manage risks and maintain a stable financial environment in the options market. The Commission granted accelerated approval for these changes to ensure timely implementation and enhanced risk management capabilities.

The Securities and Exchange Commission (SEC) has approved changes to the Nasdaq Stock Market's initial listing requirements on an accelerated basis. These changes require that companies listing on the Nasdaq Global Market or Nasdaq Capital Market through an initial public offering (IPO) meet a minimum market value of publicly held shares solely with the proceeds from the offering. Additionally, companies uplisting from the U.S. over-the-counter market will also need to meet this requirement using only IPO proceeds. The purpose of these changes is to enhance liquidity and stability for newly listed securities.

The Securities and Exchange Commission (SEC) has approved a proposed rule change allowing the NYSE Arca to list and trade shares of the Bitwise Bitcoin and Ethereum ETF under a specific rule for Commodity-Based Trust Shares. This ETF will hold both bitcoin and ether based on their market capitalizations, aiming to provide exposure to these cryptocurrencies while covering operational expenses. The SEC's approval was granted on an accelerated basis after the exchange modified its proposal to ensure transparency and fair trading practices, aligning it with other similar exchange-traded products. The public is invited to submit comments on the proposal until February 26, 2025.

The Securities and Exchange Commission (SEC) approved a rule change proposed by ICE Clear Credit LLC (ICC) to revise its Operational Risk Management Framework (ORMF). This change enhances how ICC manages risks from partnerships with core service providers, including requiring evaluations of these relationships by senior management and ICC's Board. The updates align ICC with regulatory requirements, helping ensure clear responsibilities and improving the governance and risk management of operations associated with clearing securities transactions. The approval was granted on an accelerated basis to meet the compliance date of December 5, 2024.

The Securities and Exchange Commission (SEC) has approved a proposal by NYSE Arca, Inc. to extend its trading hours. The extended trading will now allow activity from 1:30 a.m. to 11:30 p.m. Eastern Time on weekdays, barring differences on Fridays. This extension aims to foster competition by providing an additional trading venue during extended hours and includes enhanced customer disclosures to inform investors of the risks associated with trading during these hours. Also, the plan ensures that the necessary data mechanisms are in place before this extended trading can commence.