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 BioWorldfor the period, after 2024’s high of 159.
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.
The debate around the U.S. 340B prescription drug discount program is once again heating up in court and in Congress. A day after the American Hospital Association called on the FTC and Department of Justice to investigate alleged antitrust issues with the rebate models a few drug companies have proposed, some members of Congress raised concerns Sept. 9 about how providers are abusing the program. Meanwhile, a U.S. appellate court heard arguments that same day on whether states can speak in the silence of the federal law that created the program more than 30 years ago.
Researchers at Sanofi SA have developed a promising gene therapy approach targeting the microtubule-associated protein tau (MAPT) for the treatment of Alzheimer’s disease.
Myotonic dystrophy type 1 (DM1) is a rare, progressive genetic disease that causes severe muscle weakness and other debilitating symptoms, such as compromised respiration and cardiac conduction abnormalities. No disease-modifying therapy exists for DM1, so care focuses on managing symptoms like arrhythmia, myotonia, hypertension, cataracts, respiratory issues and sleep disorders.
Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.
Biopharma deal activity (excluding M&As) has surged to record-breaking levels in the first seven months of 2025, reaching $164.03 billion, well above prior years and a 36% jump over the same period in 2024.
Biopharma deal activity (excluding M&As) has surged to record-breaking levels in the first seven months of 2025, reaching $164.03 billion, well above prior years and a 36% jump over the same period in 2024.
Taking weight off with a glucagon-like peptide-1 (GLP-1) receptor agonist and keeping it off once the drug has been discontinued has been a tall order but Response Pharmaceuticals Inc. is seeing progress. Top-line results from its randomized, double-blind, placebo-controlled, parallel-group phase II study of RDX-002, in those who had already wrapped up a GLP-1 receptor agonist course for reducing obesity, were positive.