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, ...

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 ...

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.

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 ...

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 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.

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

In a conversation with Pharmaceutical Executive Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law ...

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 ...

David Rosner, principal and global life sciences customer engagement leader at Deloitte, spoke with Pharmaceutical Executive ...

The second exit in under a year follows controversy around CRLs for Replimune and Capricor, including criticism that mid- and ...

Based on the clinical trial findings, Ipsen is withdrawing Tazverik across all indications, including both follicular lymphoma and epithelioid sarcoma, and is discontinuing all active tazemetostat ...