BioSpaceOpinion

First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial

The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual ...

MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results

MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where ...
InvestorsHub on MSN

MoonLake (MLTX) shares gain after positive FDA meeting on sonelokimab filing

MoonLake Immunotherapeutics (NASDAQ:MLTX) shares rose more than 4% in premarket trading on Monday after the biotechnology ...
RAPS

FDA finalizes guidance on PSG meetings

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist sponsors in their meeting requests with the agency for products subject to product-specific guidance (PSG). The final ...
JD Supra

FDA Meeting Invites Stakeholders to Weigh in on Dietary Supplement Ingredients

On March 27, 2026, the Food and Drug Administration (“FDA”) held a public meeting entitled “Exploring the Scope of Dietary Supplement Ingredients.” Sponsored by FDA’s Office of Dietary Supplement ...
BioSpace

FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit

The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell ...
JD Supra

The Shot Heard ‘Round the Pharmacy’: FDA Takes Aim at GLP-1 Compounders

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the ...
STAT

Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field

Cell and gene therapy makers met in Rome to discuss the field's outlook in Europe. One main topic of conversation: the FDA.
Medscape

FDA Seeks Feedback on Ways to Increase Testosterone Use

The FDA is seeking feedback on whether — and how — to expand the number of men prescribed testosterone treatment. FDA Commissioner Marty Makary, MD, MPH, recently held a public forum which was ...
Regulatory Affairs Professionals Society

FDA official details top observations from QMSR inspections

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...