U.S. FDA warning letters typically have a noticeable effect on device manufacturing operations, but in the case of Q’Apel Medical Inc., a warning letter led to the withdrawal of a product for which the company made changes that were not cleared by the agency.

The U.S. FDA cleared 21 drugs for market in March, topping 16 approvals granted in February and 12 in January. That brought the first quarter (Q1) total to 49 approvals, just one short of the 50 logged in Q1 2024, making it the second-highest Q1 count in BioWorld’s records.

Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda.

The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.

The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.

The recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510(k) and PMA filings.

In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.

Xellsmart Biopharmaceutical (Suzhou) Co. Ltd. has announced IND clearances by the FDA for its XS-411 and XS-228 cell therapies, for Parkinson’s disease and amyotrophic lateral sclerosis (ALS), respectively.

Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.

In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.