FDA Complaint Filed with Center for Tobacco Products

FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-3164-0001. The complaint has been closed for comments, indicating the administrative filing process is complete. No documents are available for public review at this time.

Determination of Regulatory Review Period for ZIIHERA

FDA has determined the regulatory review period for ZIIHERA, a human biological product, as required by law for patent extension calculations. The notice invites comments on the determination and sets deadlines for challenges. Interested parties may submit comments by June 2, 2026, and petitions regarding due diligence by September 30, 2026.

EMRELIS Patent Extension Regulatory Review Period Determination

FDA has determined the regulatory review period for EMRELIS, a human biological product, for purposes of patent extension under federal law. The notice opens a public comment period until June 2, 2026, and allows interested parties to petition FDA regarding the applicant's due diligence by September 30, 2026. This determination affects the calculation of any patent term extension.

FDA Complaint Regarding Tobacco Product Regulations

The FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-2955-0001. The complaint has been closed for further comments. The specific allegations and parties involved are not publicly viewable as the underlying documents are not available for download on regulations.gov.

FDA reviews patent extension for cancer drug VYLOY

FDA reviews patent extension for cancer drug VYLOY

Restaurant Franchise Overtime Violations - IHOP Franchises in NC and SC

The U.S. Department of Labor's Wage and Hour Division recovered $95,095 in back wages for 33 cooks at three IHOP franchise locations in North and South Carolina. The investigation found Foothills Hospitality LLC, Sandhill Hospitality LLC, and Highland Hospitality LLC violated overtime provisions of the Fair Labor Standards Act by paying straight time instead of time-and-a-half for hours exceeding 40 per week. The employers also falsified payroll records by listing overtime wages as bonuses.

SEC Guidance on ATM Offerings When Public Float Drops Below $75M

The SEC Division of Corporation Finance issued Corporation Finance Interpretation 116.26 on March 19, 2026, confirming that companies conducting at-the-market offerings (ATMs) under Form S-3 may continue selling securities under an existing prospectus supplement even if their public float falls below the $75 million threshold after the offering begins. The guidance specifically addresses the 'baby shelf' rule under General Instruction I.B.6 to Form S-3.

Analysis arguing private credit AI concerns are overblown

Ankura consulting published analysis arguing that concerns about AI disruption risk in private credit portfolios are overstated. The piece challenges a UBS report estimating 25-35% of private credit portfolios face elevated AI risk, arguing that the 3-4 year average loan hold period provides sufficient duration for technology disruption to unfold gradually rather than catastrophically.

Venezuela Investment: OFAC General License Framework for Oil, Gas, Minerals

The Treasury Department's Office of Foreign Assets Control (OFAC) has issued a series of general licenses authorizing US entities and certain allied companies to engage in Venezuela's oil, gas, petrochemical, and minerals sectors. The licenses are self-executing but impose meaningful compliance obligations. The framework does not lift sanctions wholesale but establishes conditional authorization to reintroduce US economic engagement following the ouster of Nicolas Maduro in January 2026.

Minister Welcomes Prison Officer Graduates at Croke Park Ceremony

The Irish Department of Justice announced that 159 Recruit Prison Officers graduated from the Higher Certificate of Arts in Custodial Care programme, developed jointly by the Irish Prison Service and South East Technological University. The new officers have been assigned throughout the prison estate. An additional 500+ recruits are in the pipeline with the 2026 recruitment campaign to take place later this year.