Pharmaceutical Executive (independent trade outlet)

Pharmaceutical Executive Daily: FDA Plans to Remove Two Study Requirement for New Drug Approvals

The FDA announced it will drop the historic requirement for two adequate and well‑controlled studies in certain new‑drug approval pathways, a move that could accelerate timelines and lower development costs. The change is especially relevant for therapies targeting unmet medical needs, where evidentiary flexibility may speed patient access. Meanwhile, Hims & Hers Health agreed to acquire Eucalyptus for $1.15 billion, expanding its digital‑health platform internationally. Industry leaders are also focusing on de‑bottlenecking early‑stage trials to further shorten time‑to‑market.