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In today's Pharmaceutical Executive Daily, Eli Lilly releases updated safety data for its oral obesity pill Foundayo in response to an FDA post-approval request, ICER and Verdant Research publish a new white paper examining the evolution and future of the FDA's accelerated approval pathway, and a new Pharmaceutical Executive commentary argues FDA's shift toward single-trial approval standards marks the beginning of a genuinely new era in data-driven drug development.

A new ICER white paper calls for reforms to the FDA’s accelerated approval pathway, citing ongoing challenges with regulatory consistency, confirmatory trial delays, and transparency.

Eli Lilly releases new safety data after FDA requested additional data to conduct extensive post-approval safety studies for Foundayo, including long-term monitoring of cardiovascular, liver, and thyroid cancer risks.

Samsung Bioepis’ Thomas Newcomer explains the reasons why biosimilar developers are or are not feeling confident about the consistency of the US market in the coming years.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses why J&J was chose for the CNPV program and it's experience during the process.

Elevating real-world data (RWD) to the status of regulatory-grade evidence will bring both opportunity and challenges to the industry.

Recent breakthroughs in artificial intelligence allow specialized language models to automatically extract critical information from thousands of complex drug labels in minutes instead of days.

Biotech financing activity this week underscores strong investor backing for platform-driven innovation, with capital flowing into ADC development, precision immunology, multi-cancer diagnostics, and non-invasive oncology technologies aimed at addressing persistent gaps in care.

Obsidian Therapeutics and Galera are merging to form a Nasdaq-listed cell therapy company backed by a $350 million private placement, aiming to advance OBX-115, a next-generation TIL therapy.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, notes select influences of how the Phase III clinical testing was conducted.

A more dynamic, data-driven approach is redefining what “good” looks like in copay support.

In today's Pharmaceutical Executive Daily, AbbVie licenses a portfolio of pain compounds from China's Haisco Pharmaceutical in a deal worth up to $745 million, the FDA grants full approval to Filspari as the first and only approved treatment for focal segmental glomerulosclerosis, and Pharmaceutical Executive speaks with Deepak Prakash of Identiv on how RFID and real-time tracking are building operational visibility in clinical trials.

AbbVie entered a global licensing deal with Haisco worth up to $715 million to expand its pain pipeline with several assets.