A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals.
FDA tells Aquestive Therapeutics that deficiencies have been identified in the companys NDA for Anaphylm that currently preclude labeling and post-mar...
FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly.
A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Squibbs Karuna Therapeutics unit underscores the agenc...
CDERs Office of Prescription Drug Promotion sends BeOne Medicines USA an untitled letter over its promotional materials for cancer immunotherapy Tevim...
Representatives of FDA and the drug industry make progress in PDUFA 8 discussions on real-world evidence and metrics for first-cycle review.
A new analysis from Harvard Law School argues that the U.S. drug regulators reliance on industry-paid user fees has left the agency vulnerable to both...
FDA approves 46 novel new drugs and 18 new biologics in 2025, fewer than in the previous two years, likely due to the staffing turmoil the agency expe...
