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Greater Miami is rapidly emerging as an international biotech hot spot—as capital, talent, and infrastructure converge to transform the region from a tourism-driven economy into a globally connected life sciences innovation hub.

CSL Limited has licensed global development and commercialization rights for clazakizumab to Eli Lilly and Company outside of ESKD-related cardiovascular risk.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary Robert F. Kennedy Jr. revises the agency’s leadership team, and industry expert Sandy Tammisetty discusses what it takes to deliver actual value in today’s pharmaceutical landscape.

HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the administration’s health policy priorities.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

Without new legislation, pilot programs, or years of rulemaking, the agency could use enforcement discretion to create a fast, risk-based pathway for low-risk early-stage trials.

As the pharma industry continues to experiment with AI implantation, certain areas are showing more promise than others.

Model N’s SVP details the implications of the various deals major pharma companies are striking with the government over drug pricing.

Following the decisions=, the European Commission decided to close a long-running antitrust investigation

The letter follows Phase II data that did not sufficiently link biomarker reductions to clinical benefit.

Most medical digital pilots are designed for success in controlled conditions.

EVERSANA’s president of Patient Services discusses using technology to bring a personalized approach to change care.