The FDA continues to issue critical regulatory decisions impacting biotech pipelines. Notably, Lenz Therapeutics received U.S. approval for its aceclidine-based eye drop for presbyopia, marking a challenging but significant market entry. Conversely, Regeneron's odronextamab encountered multiple complete response letters linked to manufacturing issues. Additionally, the FDA mandated opioid label updates to emphasize risks of long-term use. Several PDUFA dates are scheduled in August across various programs, underscoring a dynamic approval landscape.