FDA
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
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The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.
Experts express concern that last week’s unprecedented FDA layoffs will trigger a little-known mechanism that could result in a “disaster” the Trump administration doesn’t see coming.
The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst.
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.
The FDA has asked for another well-controlled trial to establish the efficacy of reproxalap in dry eye disease.
The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund employee salaries. An analysis from AgencyIQ suggests that the agency is dangerously close to losing it all.
In the Phase III MITIGATE trial, Uplizna cut IgG4-related disease flares by 87% versus placebo.
The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency’s principal deputy commissioner intervened.
Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the reins in a department inside an agency beset by cuts, layoffs, and confusion.
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.