The U.S. Department of Health and Human Services (HHS) has signed a legal determination terminating the Emergency Use Authorization (EUA) for COVID-19-related drugs, biologics, and medical devices. This decision follows the lifting of the pandemic emergency and reflects the government's assessment that the legal and clinical justification for maintaining the EUA framework no longer exists. Consequently, therapeutics and biologics will have a 12-month grace period before the EUA is fully terminated on June 29, 2027. Medical devices and in vitro diagnostics will have a shorter grace period of 180 days, with approvals expiring on December 26, 2026.

This decision places immediate regulatory pressure on therapeutics that have only been available under EUA and have not yet secured full marketing authorization (NDA/BLA). Key products affected include Merck's Lagevrio (molnupiravir) and Invivyd's Pemgarda (pemivibart). Lagevrio generated $964 million in revenue in 2024, while Pemgarda recorded $53.4 million in revenue in 2025, making them significant assets. These companies now face the serious prospect of being completely withdrawn from the U.S. market if they fail to obtain full NDA approval within the one-year grace period.

In contrast, companies that have already received full FDA approval (NDA/BLA) are poised to consolidate their market dominance. Pfizer's Paxlovid (nirmatrelvir/ritonavir) has received full approval for adult use, and Gilead Sciences' Veklury (remdesivir) has also secured full approval. Paxlovid generated $5.451 billion in revenue in 2024, and with Lagevrio potentially exiting the market, it is expected to capture a significant share of that market. This regulatory shift favors large pharmaceutical companies that have already overcome the regulatory hurdles.

The termination of the EUA framework signifies a return to a standard treatment paradigm with rigorous safety and efficacy verification. Companies seeking to launch new COVID-19 drugs will need to demonstrate complete clinical trial data and adherence to stringent Current Good Manufacturing Practice (cGMP) standards. This will create significant regulatory barriers for new entrants, requiring substantial investment and longer development timelines. While this will ultimately enhance patient safety and trust in medications, it will also increase the R&D burden for smaller biotech companies.