FDA Related News

Human Drugs

Fast Track for Alessas Prostate Cancer Therapy

FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.

Medical Devices

AVID Medical Recalls Organ Recovery Bags

AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.

Human Drugs

FDA Guide Outlines Expectations for Bayesian Trial Designs

A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals.

Human Drugs

FDA Flags Deficiencies in Aquestives Anaphylm NDA

FDA tells Aquestive Therapeutics that deficiencies have been identified in the companys NDA for Anaphylm that currently preclude labeling and post-mar...

Human Drugs

FDA Accepts Camurus NDA Resubmission for Acromegaly Drug

FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly.

Marketing

Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Squibbs Karuna Therapeutics unit underscores the agenc...

Human Drugs

FDA Flags BeOne Tevimbra Promotional Materials

CDERs Office of Prescription Drug Promotion sends BeOne Medicines USA an untitled letter over its promotional materials for cancer immunotherapy Tevim...

Human Drugs

PDUFA 8 Negotiations on RWE, First-Cycle Reviews

Representatives of FDA and the drug industry make progress in PDUFA 8 discussions on real-world evidence and metrics for first-cycle review.

FDA General

Harvard Law Hits User Fees Over Corporate Capture

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...

Drug, Biologic Approvals Drop in 2025

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...