Regulatory Update

Ras Al Khaimah – September 21, 2026 -- ARIDGE, formerly XPENG AEROHT and Asia's largest flying car company, has signed a strategic cooperation agreement with the Emirate of Ras Al Khaimah to establish what both parties describe as the world's first regulatory sandbox dedicated to personal low-altitude flight.

The agreement was signed in the presence of His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, under oversight of the UAE General Civil Aviation Authority (GCAA). The deal makes ARIDGE the first Chinese flying car company to enter a national-level regulatory sandbox in the Middle East.

Rochester, Mich. – September 21, 2026 -- Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) at the hospital level after detecting particulate matter identified as cellulose or stopper material.

Contaminated vials carry risk of pulmonary emboli and vessel occlusion

The FDA-notified recall covers Lots 87558 and 88802, which were distributed nationwide to wholesalers between September 21, 2026 and September 21, 2026. Par Health warned that administering the affected product carries a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels that can lead to tissue death and organ damage, and inflammation of vein walls that may result in clotting. The company said it has not received any adverse event reports tied to the recall to date.

Sacramento – September 21, 2026 -- California Governor Gavin Newsom signed an executive order accelerating implementation of SB 813, the Fathom-sponsored law that established the nation's first comprehensive framework for independent verification organizations (IVOs) overseeing frontier AI systems.

California moves IVO designation deadline up by eight months

The executive order shifts the state's deadline to finalize IVO designation criteria from January 2028 to May 2027. SB 813 already created the legal structure for IVOs, third-party bodies tasked with independently assessing AI labs' safety claims.

New York – September 21, 2026 -- Invictus Pharmacy has secured LegitScript Healthcare Merchant Certification for its platform InvictusPharmacy.com, joining a select group of digital pharmacy operators that includes Amazon Pharmacy in meeting the certifier's compliance standards.

LegitScript certification confirms pharmacy licensing and prescription validity standards

The certification evaluates pharmacy licensing, regulatory compliance, patient privacy protocols, valid prescription practices, website transparency and advertising conduct. Invictus Pharmacy's approval places it among established platforms cleared to operate within the regulated digital healthcare marketplace.

Washington – September 21, 2026 -- The American Association of Kidney Patients (AAKP) has endorsed Health and Human Services Secretary Robert F. Kennedy Jr.'s new appointments to the U.S. Preventive Services Task Force (USPSTF), following a years-long campaign by the group to force reforms on kidney disease screening policy. AAKP President Edward V. Hickey III said the appointees bring the diverse credentials needed to advance patient-centered medicine after what the organization calls two decades of Task Force inaction on kidney health.

Indianapolis – September 21, 2026 -- The U.S. Food and Drug Administration has granted full approval to Eli Lilly and Company's (NYSE: LLY) Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

EMBER-3 trial shows combination doubles progression-free survival

The approval rests on Phase 3 EMBER-3 data in 159 patients with ESR1-mutated metastatic breast cancer who had previously received an aromatase inhibitor, with or without a CDK4/6 inhibitor. Patients randomized to Inluriyo plus Verzenio (n=67) achieved a median progression-free survival of 11.1 months, versus 5.5 months for Inluriyo alone (n=92), a hazard ratio of 0.53 (95% CI, 0.35–0.80).

Mexico City – September 21, 2026 -- The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded full accreditation to Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), making it the first of Mexico's 13 National Institutes of Health under the Mexican Ministry of Health to reach this status.

INCMNSZ becomes only the second organization in Mexico to earn AAHRPP accreditation, joining a global roster that now exceeds 600 accredited entities. AAHRPP separately confirmed reaccreditation for five additional organizations, underscoring continued renewal activity within its existing accredited network.

Norcross, Ga. – September 20, 2026 -- Koning Health's Breast CT System, the CBCT 1000, has been added to the Australian Register of Therapeutic Goods (ARTG No. 531059), clearing the device for commercial supply in Australia.

TGA approves device inclusion on September 8, 2026

The Therapeutic Goods Administration granted the ARTG listing on September 8, 2026, allowing Koning Health to begin commercial supply in Australia subject to regulatory conditions tied to the inclusion.

Brisbane Radiology becomes first Australian buyer of the system

Brisbane Radiology has committed to purchasing the Koning Breast CT System, making it the first provider in the country to adopt the technology. Clinical Director Jacqui Milne said the approval marks a milestone for breast imaging in Australia and expects it to create new opportunities for patients and providers nationwide.

Helsinki – September 20, 2026 -- Finland's Financial Supervisory Authority approved a supplement to UPM-Kymmene Corporation's demerger and listing prospectus on September 20, 2026, formalizing Lasse von Hertzen's appointment as permanent Chief Financial Officer of WISA Group Plc, the entity being spun off from UPM.

Finnish regulator clears prospectus supplement for UPM's WISA spin-off

The approved supplement amends the Finnish-language demerger and listing prospectus tied to UPM's partial demerger, which is scheduled for completion on September 20, 2026. Trading in WISA shares on the regulated market of Nasdaq Helsinki Ltd is expected to begin on September 20, 2026, or as soon as reasonably possible thereafter. UPM is publishing the supplement on WISA's behalf, alongside unofficial English translations available via UPM's demerger information channels.

Hamilton – September 20, 2026 -- Paratus Energy Services Ltd. confirmed that Petrobras has accepted a bid submitted by its Seagems joint venture for a third-party vessel under the state oil company's ongoing pipe-laying support vessel (PLSV) tender process for contracts starting in 2028.

Petrobras Publishes Partial Tender Results Favoring Seagems Bid

Petrobras has issued partial results from the tender, confirming acceptance of the bid covering the third-party vessel. The award remains subject to a formal Petrobras contract decision and the execution of definitive agreements between the parties.