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The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to consolidate into a single robust pivotal study.

Conversational AI is pushing engagers to prioritize clear, explainable guidance as patients and clinicians delegate understanding to chatbots.

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the second time in under a year, major deal activity including a GSK and Alfasigma licensing agreement along with Servier’s $2 billion acquisition of Day One Pharmaceuticals, and Ipsen withdraws Tazverik from the market following emerging clinical trial data.

The deal comes after Novo took legal action against Hims to prevent the company from offering compounded GLP-1 medications.

Ipsen is withdrawing its EZH2 inhibitor Tazverik from all markets after an ongoing clinical trial identified safety concerns involving secondary blood cancers.

The vaccine chief briefly left the role last summer before almost immediately returning to it.

The GSK licensing deal is reportedly worth up to $690 million.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes shifting regulatory signals for Moderna’s mRNA flu vaccine review and raises broader questions about the stability of the approval pathway.

The drug is part of the Commissioner’s National Priority Review Voucher program.

FDA informed uniQure it will not accept external control data as the primary basis for approving AMT-130, instead demanding a prospective, randomized, sham surgery-controlled trial before moving forward.

Market access strategies are evolving as more biopharma companies commercialize their own therapies, requiring closer alignment with payer requirements, provider education, specialty pharmacy networks, and patient support services to ensure appropriate coverage, prescribing, and long-term adherence.

In the second part of his conversation with Pharmaceutical Executive, Ajna Biosciences CEO Joel Stanley explains the complexities of getting a botanical drug approved.

From data risk to relationship equity, the need to rethink consent in life sciences marketing.

The business and market models drugmakers must continually adapt to stay competitive as 2026 progresses.

In today’s Pharmaceutical Executive Daily, Cognito Therapeutics and Nexcure secure new financing rounds to advance their pipelines, artificial intelligence and large language models reshape pharmacovigilance and drug safety monitoring, and Eli Lilly launches a new Employer Connect platform to expand obesity treatment coverage options.

Cognito Therapeutics and NexCure have each closed new funding rounds this week, advancing an at-home Alzheimer's stimulation device and a platform to bring CAR-T therapy to community settings

Large language models and natural language processing are reshaping drug safety surveillance by enabling automated adverse event detection, large-scale analysis of regulatory labeling data, and faster, citation-grounded safety assessments while maintaining human oversight and regulatory compliance.

Eli Lilly launches Employer Connect, a new platform linking employers with benefit administrators and a pharmacy network to expand affordable access to its obesity medication Zepbound for U.S. workers.

Alice Valder Curran discusses how the industry continues to strategize around this complicated order.

In today’s Pharmaceutical Executive Daily, Antengene and UCB enter a billion-dollar global licensing agreement for a bispecific T-cell engager, Teva signs a $400 million strategic growth capital agreement with Blackstone Life Sciences, and industry leaders explore the technological renaissance driven by AI integration.

In this Pharmaceutical Executive Academy discussion, Najat Khan, PhD, CEO of Recursion Pharmaceuticals and former chief data science officer at J&J, explores the intersection of AI, pharma, and patient care — and the strategic pivots necessary to drive measurable and lasting gains across the value chain.

The agreement is focused on advancing ATG-201, a bispecific T-cell engager therapy targeting B cell-driven autoimmune diseases.

Teva Pharmaceuticals has secured $400 million from Blackstone Life Sciences to advance duvakitug, an experimental monoclonal antibody in Phase III trials for ulcerative colitis and Crohn's disease.

Ajna Biosciences CEO Joel Stanley discusses the differences between botanical drugs and botanically-derived drugs.

As AI rapidly reshapes drug development and clinical operations, industry leaders say transparency, governance, and strong data foundations will determine whether the technology accelerates innovation or stalls under regulatory and operational pressure.

The gap between AI’s abilities and how people use could be about capability, but it’s also about confidence, belief and mindset.

In today’s Pharmaceutical Executive Daily, industry leaders examine how to measure AI’s return on investment across the life sciences value chain, Novo Nordisk commits $506 million to expand its Ireland manufacturing facility, and Bavarian Nordic CEO Paul Chaplin announces plans to step down.