In 2025 it seemed the only certainty for biotech was more uncertainty. Biotech leaders conducted business as usual against the background of ongoing funding challenges and ever-increasing drug ...

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, ...

Senators are probing which products fall under Medicaid-related deal provisions and whether any “MFN” prices are meaningfully lower than current Medicaid net prices after rebates.

In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA ...

In today's Pharmaceutical Executive Daily, the FDA approves leucovorin as the first-ever treatment for an ultra-rare genetic condition called cerebral folate transport deficiency, Enhertu receives FDA ...

FDA granted Priority Review to AstraZeneca’s supplemental application for Enhertu in early-stage HER2-positive breast cancer, moving the drug closer to a potential new indication for patients at high ...

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 ...

FDA granted a narrow indication for CFD-FOLR1, targeting impaired folate transport into the CNS that drives developmental delay, seizures, movement disorders, and autistic features in some patients.

Arthur G. Cook is Principal, ZS Associates.

Conversational AI is pushing engagers to prioritize clear, explainable guidance as patients and clinicians delegate understanding to chatbots. OpenAI’s announcement of ChatGPT Health and Anthropic’s ...

After weeks of legal drama, Ozempic is coming Hims & Hers, a telehealth company. Novo Nordisk came to an agreement with the company to offer various doses of the GLP-1 medication for DTC customers. 1 ...

In today’s Pharmaceutical Executive Daily, Vinay Prasad exits the FDA’s Center for Biologics Evaluation and Research for the ...