Bubs Australia secured permanent authorization from the FDA (U.S. food and drug regulator) to sell three infant-formula products in the United States, sending its shares as much as 45% higher to A$0.145, their highest level since January 14. The move put the stock on course for its biggest one-day gain since May 2022. The company is also evaluating entry into the U.S. private-label infant-nutrition market as it seeks to diversify beyond China. The approval comes amid tighter regulations and supply-chain disruptions affecting infant-nutrition companies in Australia and New Zealand. Bubs reported a A$1.8 million ($1.30 million) annual EBITDA loss last month, but expects a stronger first half in 2027, supported by U.S. demand. New Zealand-based dairy company a2 Milk separately said supply constraints hurt earnings in its annual results last month, underscoring the sector’s operational and regulatory challenges.