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Pharmaceutical Executive Daily: FDA Expands Approval of Leucovorin

FDA Approves Leucovorin Without a Clinical Trial for Cerebral Folate Transport Deficiency: Report

FDA Grants Priority Review to Enhertu as Treatment for Patients with HER2-positive Early Breast Cancer

How FDA's Removal of the Two-Trial Requirement Affects Development Programs

AI has Redefined Healthcare Communication — and There’s No Opting Out

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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.

Pharma companies choosing between Salesforce and Veeva’s CRM has larger implications than many expect.

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
























