Search Results for keywords:"Accelerated Approval"

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Search Results: keywords:"Accelerated Approval"

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  • 2025-02084 — Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing of Amendment No. 2 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 2, Regarding the Types of Complex Orders Available for Flexible Exchange Options (“FLEX”) Trading on the Exchange
    Type:Notice
    Citation:90 FR 8822
    Reading Time:about 40 minutes

    The Securities and Exchange Commission has approved a new rule change proposed by Cboe Exchange, Inc. to broaden the types of complex orders available for trading Flexible Exchange Options (FLEX). Previously, investors could only trade FLEX Options in separate orders if they included both FLEX and non-FLEX securities. The updated rule allows for a new type of complex order, called "FLEX v. Non-FLEX Order," which combines FLEX and non-FLEX components within the same order. This approval is designed to streamline trading by reducing price and legging risks, thereby offering more flexibility and efficiency in managing investment strategies.

    Simple Explanation

    The rules have changed to make it easier for people trading certain types of special stock options, called FLEX options, to do so in a way that combines both special and regular parts in one order. This change helps save time and money and lets them trade more safely.

  • 2025-01179 — Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period
    Type:Notice
    Citation:90 FR 5899
    Reading Time:about 4 minutes

    The Food and Drug Administration (FDA) is extending the time for public comments on its draft guidance concerning the expedited approval process for drugs and biologics intended for serious conditions. Originally published on December 6, 2024, the comment period has been extended by 30 days, now closing on March 6, 2025. This extension was granted following requests expressing that the initial 60 days were insufficient to provide thorough feedback. The draft guidance aims to streamline the approval pathway for treatments addressing critical health issues.

    Simple Explanation

    The FDA is giving people more time to say what they think about new rules for quickly approving important medicines, like if you're really sick and need new treatments. They were supposed to finish talking about it by February, but now they have more time until March 6, 2025.