Recently Featured

Trump’s CMS to Allow Skimpier Plans on ACA Exchanges

June 14, 2026
The Trump administration is set to implement changes that will permit Affordable Care Act (ACA) exchanges to offer plans with minimal coverage and reduced protections, while simultaneously lowering monthly premiums. This decision, finalized by the Centers for Medicare and Medicaid Services (CMS), will take effect in 2027 and marks a significant shift in the regulatory…

Ongoing Cancer Accelerated Approvals Highlight Regulatory Landscape

June 14, 2026
The FDA continues to grant accelerated approvals (AAs) for various malignant hematology and oncology indications, emphasizing the need for ongoing clinical trials to verify clinical benefits. These AAs are crucial in expediting access to potentially life-saving therapies, particularly in areas where treatment options are limited. However, the requirement for postmarketing studies underscores the regulatory commitment…

FDA’s Unreleased Covid Vaccine Deaths Report Published by Lawmaker

June 14, 2026
An analysis initiated by former FDA leaders regarding allegations of pediatric deaths linked to Covid-19 vaccines has been made public by a Republican lawmaker. This release comes months after the FDA’s self-imposed deadline to produce the report, raising questions about the agency’s transparency and responsiveness to public health concerns. The delay in publication has sparked…

Novartis terminates plant contract with Chinese CDMO Porton, threatens $64M in legal claims

June 13, 2026
Novartis has unilaterally terminated its plant leasing contract with Chinese contract development and manufacturing organization (CDMO) Porton Pharma Solutions, a move that could result in legal claims amounting to $64 million. This decision follows a regulatory issue that has raised concerns about compliance and operational integrity at the facility. This development underscores the complexities and…

Ongoing Cases