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Study results showed that patients saw three years of remission while taking the medication.

Hims & Hers has agreed to acquire Australia-based Eucalyptus for up to $1.15 billion, expanding its international footprint across Australia, Canada, Germany and the U.K.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

In today’s Pharmaceutical Executive Daily, the FDA begins reviewing Moderna’s seasonal flu vaccine under a revised regulatory approach, Eli Lilly signs a $100 million licensing agreement with CSL for an anti- IL-6 monoclonal antibody., and Southern Florida emerges as a growing biotech hub.

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.

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.

In today’s Pharmaceutical Executive Daily, the FDA issues a Complete Response Letter for Disc Medicine’s bitopertin in EPP, Edwards Lifesciences lifts its anti-copycat policy, and industry leaders examine how to scale global medical digital transformation while ensuring local fit.