The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...

While pricing pressures will vary and orphan products can expect some protection now, the suggestion here is that brand planning should evaluate the merits of risk contracting for the future. At least ...

Internal criteria allowed cancelling adverse event reports when reporters believed events were unrelated to therapy, conflicting with FDA requirements to submit serious, unexpected events irrespective ...

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.

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, 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 ...

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 ...

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 ...

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 ...