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Lilly and Regeneron Among First Incumbents to FDA’s Fast-Track Facility Scheme

July 21, 2026
Seven pharmaceutical companies, including Eli Lilly and Regeneron, have been selected for the FDA’s PreCheck pilot program, a strategic initiative aimed at enhancing the resilience of the U.S. drug supply chain. This pilot is designed to streamline the regulatory process for facilities that meet specific criteria, thereby expediting the approval of critical medications. The inclusion…

Viridian may have edge over Amgen in eye drug showdown, analysts argue

July 21, 2026
The FDA has granted a new approval for Viridian’s drug, which analysts suggest could provide a competitive advantage against Amgen’s Tepezza in the expanding thyroid eye disease market. This development is seen as a pivotal moment for Viridian, as the updated labeling may enhance its market positioning and appeal to healthcare providers. Contextually, the thyroid…

Top FDA gene and cell therapy regulator to step down

July 21, 2026
Vijay Kumar, a prominent figure in the FDA’s gene and cell therapy division, is set to step down, leaving a significant leadership void at the Center for Biologics Evaluation and Research (CBER). This transition occurs at a critical juncture as the agency grapples with evolving regulatory frameworks surrounding innovative therapies. As Kumar departs, Karim Mikhail…

Medical journal retracts Tavneos pivotal study article, complicating Amgen’s defense effort

July 21, 2026
Amgen’s rare disease treatment, Tavneos, faces a significant setback following the retraction of its pivotal study article by a prominent medical journal. This development comes amid increasing scrutiny from the FDA regarding the drug’s safety and efficacy, raising concerns about its market viability. The retraction not only undermines the credibility of the clinical data supporting…

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