A graphical depiction of outgoing FDA Chief Counsel Stacy Cline Amin's list.
A graphical depiction of outgoing FDA Chief Counsel Stacy Cline Amin's list.
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Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.
CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.
Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.
Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.
Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.
Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
