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

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, the FDA reportedly removes its two-study requirement for new drug approvals, Hims & Hers enters a $1 billion agreement to acquire Eucalyptus, and experts examine how FDA can help ease early-stage clinical trial bottlenecks.

In regulatory news, the U.S. Food and Drug Administration has reportedly removed its longstanding requirement for two adequate and well-controlled studies in certain new drug approval pathways. If broadly implemented, the change could streamline development timelines, reduce costs, and reshape evidentiary standards, particularly for therapies addressing unmet medical needs. Industry stakeholders are watching closely to see how this shift affects regulatory strategy and approval predictability.

Hims & Hers Health has entered a $1.15 billion agreement to acquire Eucalyptus, marking a major expansion of its global digital health footprint. The deal is expected to strengthen Hims & Hers’ presence in international markets and broaden its direct-to-consumer care platform. The acquisition underscores continued consolidation in the virtual care space as companies scale operations and diversify service offerings.

Finally, attention is turning to how the FDA can help de-bottleneck early-stage clinical trials. Sponsors and regulators alike are exploring ways to modernize trial design, improve communication, and accelerate protocol review processes. By addressing inefficiencies at the earliest phases of development, the industry hopes to reduce delays downstream and bring innovative therapies to patients faster.

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