
Regulatory
Latest Content

FDA Awards Priority Voucher to Compass for Psychedelic Therapy in Treatment-Resistant Depression

Pharmaceutical Executive Daily: FDA Issues CRL to AbbVie

FDA Issues CRL to AbbVie for TrenibotulinumtoxinE’s Biologics License Application

Regeneron Agrees to Lower Drug Costs for U.S. Patients and Provide Otarmeni for Free

The Long Wait for Rare Disease Treatment Approval: Q&A with Dr. Patricia E. Greenstein

Shorts










Podcasts
Videos
All News

Maher Masoud, CEO of MaxCyte, explains how the current environment is impacting the entrepreneurial spirit in the pharmaceutical industry.

In this episode, Ron Lanton examines how geography is becoming a central strategic variable in healthcare, as policy, trade dynamics, and infrastructure increasingly dictate where innovation is developed, manufactured, and commercialized.

Early clinical data from the CHORD trial supported accelerated approval of the first gene therapy targeting OTOF-related hearing loss under the FDA Commissioner’s National Priority Voucher program.

In today’s Pharmaceutical Executive Daily, the FDA expands the use of Tzield to young children to delay the onset of stage 3 type 1 diabetes, Dupixent receives an expanded pediatric indication in chronic spontaneous urticaria, and AbbVie announces a $195 million investment to build a new manufacturing campus in North Carolina.

FDA expands its approval of Tzield to children as young as one with stage 2 type 1 diabetes, extending the first disease-modifying therapy into an earlier, high-risk population to delay progression to insulin-dependent disease.

EVERSANA’s president discusses the evolving role of the Asembia conference, emerging commercialization trends, and what’s top of mind for pharma leaders this year.

FDA Expands Approval for Dupixent for Young Children with Uncontrolled Chronic Spontaneous Urticaria
FDA expands Dupixent approval to children aged 2–11 with chronic spontaneous urticaria, marking the first biologic option for this population and extending its reach across type 2 inflammatory diseases.

AbbVie has announced a $1.4 billion investment to build a new pharmaceutical manufacturing campus in North Carolina, expanding its U.S. footprint with a focus on advanced sterile injectable production.

MaxCyte CEO Maher Masoud discusses how new treatment methods are providing greater control of the therapy’s safety profile.

In today’s Pharmaceutical Executive Daily, the FDA approves a new treatment for HIV-1 infection in adults, Amazon One Medical launches a GLP-1 weight management program, and a new report highlights which top-selling drugs are most at risk of supply shortages.

FDA has approved Merck’s Idvynso, introducing a differentiated, two-drug, non-INSTI, tenofovir-free HIV regimen that maintains viral suppression while offering a potentially more tolerable, simplified option for long-term patient management.

Amazon has launched a new GLP-1 weight management program through its One Medical network, integrating obesity treatment into primary care while expanding access to both telehealth services and a range of branded medications.

Enabling highly individualized treatment approaches that align with each patient’s unique physiology, goals, and tolerability, compounding can have a significant impact.

Supply chain chokepoints are converging to expose deep structural vulnerabilities in the U.S. drug supply, with new data showing that even medicines not currently in shortage may be one disruption away from crisis.

In today’s Pharmaceutical Executive Daily, UnitedHealth raises its full-year profit forecast following stronger-than-expected first-quarter results, Pfizer works to reshape its leadership narrative as it approaches a major patent cliff, and a new industry perspective highlights why scaling artificial intelligence in pharma requires more than just advanced algorithms.
























