Eli Lilly received approval from the U.S. Food and Drug Administration for orforglipron, now branded as Foundayo, according to an April 8 announcement. This development marks the beginning of a new phase in the ongoing competition between Lilly and its main rival, Novo Nordisk.
The approval of Foundayo is significant because it introduces another oral treatment option into a market where efficacy and convenience are important factors. While oral Wegovy from Novo Nordisk demonstrated slightly higher efficacy in Phase 3 trials—showing over 16% compared to Foundayo’s reported 11%—no direct head-to-head clinical trials have been conducted between the two drugs. However, Foundayo may offer greater convenience since it does not require water for administration, unlike Novo’s pill.
In addition to drug approvals, merger and acquisition activity remains strong in the pharmaceutical industry. Gilead Sciences has acquired its partner Tubulis for up to $5 billion, while Neurocrine Biosciences has purchased Soleno Therapeutics for $2.9 billion. Analysts indicate that companies such as Amgen, AbbVie, and Bristol Myers Squibb may also be seeking further acquisitions given their available resources.
Policy changes are also affecting the sector. President Donald Trump announced new tariffs on pharmaceutical products but included several carveouts that will exempt many companies from a proposed 100% tax at this time. The administration’s Most Favored National pricing scheme is influencing drug launches in Europe as some companies avoid introducing new products in countries that could lower U.S. prices.
The Trump administration released its proposed budget for 2027 last Friday with requests aimed at accelerating therapy development for rare diseases through agencies like the FDA and Department of Health and Human Services. Among these proposals are permanent authorization of the rare pediatric disease priority review voucher program, creation of a new clinical trial notification pathway, and expanded regulatory authority over post-approval manufacturing changes.
Industry leaders continue to call for clarity around topics such as externally controlled trials amid ongoing efforts by regulators to balance rigorous oversight with unmet medical needs.
