The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022. Despite the decrease from last year, the 2025 total remains the second-highest in BioWorld’s records for this time frame.

Even before the Trump administration’s executive order wiping out the concept of diversity, equity and inclusion, the statistics on female representation in the biotech industry painted a story of stagnating progress. But for Jane Wall, managing director of the U.K. Bioindustry Association (BIA), the available statistics also begged a question: Where was the U.K. specific data that could inform attempts to change things? There was “much frustration around stats being recycled without context or background – and very little our community could relate to,” Wall said.

The BioWorld Drug Developers Index underperformed both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) throughout February and March. However, it showed some recovery by the end of April, finishing the month down 4.67%, slightly worse than the DJIA’s 4.41% decline. The NBI ended April slightly up from both, with a year-to-date drop of 1.16%.

Recognizing the potential legal challenges to U.S. President Donald Trump’s executive order calling for most-favored-nation (MFN) prescription drug pricing and the limits of that order, several congressional Democrats introduced a bill in both the House and Senate May 14 that could make MFN pricing the law of the land and extend it to both government health programs and private insurance.

South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.

Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.

Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.