The U.S. FDA cleared 18 drugs in August, comparable to July’s 17 but down from June’s 23 approvals. That brings the 2025 U.S. total through August to 143, matching 2020 as the second-highest count on record for BioWorld for the period, after 2024’s high of 159.

As Wall Street awaits phase IIb data from Kala Bio Inc. with KPI-012 in persistent corneal epithelial defect, odds are being weighed for that candidate – and others in development – against the lone approved treatment used in a market already worth more than $1 billion.

Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.

Drug developer stocks rebounded over July and August, with 23 companies on the BioWorld Drug Developers Index posting gains and only seven declining. The two-month upswing marks a reversal from the February-through-June period, when the index remained in the negative.

Biopharma dealmaking remained robust through August 2025, with total disclosed deal value reaching $185.28 billion for the first eight months of the year, the highest January-to-August total in BioWorld’s records, and up nearly 36% over the same period in 2024.