Italy & United States — Food and Drug Administration

Italy: Neridronate is already approved in Italy for CRPS and other indications, with approximately 600,000 patients treated. This provides real-world evidence supporting its safety and efficacy.

United States — Food and Drug Administration: The FDA has granted Breakthrough Therapy, Fast Track, and Orphan Drug designations to neridronate, and has aligned that a single successful pivotal trial could support approval. FDA decisions will be pivotal for the combined company's future.

Italy: Italy>>> triggered protocols for a suspected Ebola case after a patient returned from the Democratic Republic of the Congo>>>. Although the patient tested negative, the incident highlights the global concern and the need for vigilance in non-affected countries.

United States — Food and Drug Administration: The United States — Food and Drug Administration has approved Inmazeb, a combination of antibodies, to treat Zaire Ebolavirus infection, which Regeneron Pharmaceuticals has donated for potential use in the current outbreak.

Italy: Italian prosecutors are investigating Dalcon Construction for alleged labor exploitation in Italy — Milan, highlighting labor issues within the country.

United States — Food and Drug Administration: The United States — Food and Drug Administration is the regulatory body that Revolution Medicines will seek approval from for its experimental pancreatic cancer drug, daraxonrasib.