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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.

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.

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.

As therapeutic complexity increases, life sciences companies should cultivate open mindsets toward innovative data sources beyond traditional claims and electronic medical record data.

Eli Lilly's $1.5 billion pre-launch inventory of orforglipron signals an aggressive manufacturing strategy aimed at avoiding supply shortages and capturing early share in the competitive obesity market.

From lessons in risk-taking—and building “from zero”—to career-defining pivots, Leonard Mazur, CEO of Citius Pharmaceuticals, reflects on 50-plus years in pharma.

The withdrawal is due to data shared from FDA reflecting that data included in the NDA submission is unlikely to meet the required threshold of evidence.