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FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modernize nonclinical studies, with upcoming steps focused on scaling alternative methods, improving data infrastructure, and tightening global coordination.

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President Trump signs an executive order aimed at accelerating the development and availability of psychedelic-based treatments for patients with serious mental illness.

LATEST NEWS

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FDA Lays Out Next Phase of Plan to Reduce Animal Testing

FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modernize nonclinical studies, with upcoming steps focused on scaling alternative methods, improving data infrastructure, and tightening global coordination.

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Trump Signs Executive Order to Accelerate Psychedelic Therapies

President Trump signs an executive order aimed at accelerating the development and availability of psychedelic-based treatments for patients with serious mental illness.

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Padcev-Keytruda Combo for Broader Bladder Cancer

FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to expand its use for patients with muscle-invasive bladder cancer.

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Philips Wins Clearance for AI-powered Spectral CT System

FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-based spectral CT scanner.

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Animal Drugs

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medical-devices
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Lilly to Seek FDA Approval for Foundayo in Diabetes

Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...

medical-devices
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2 CDER Postmarketing MAPPS Out

CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.

medical-devices
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Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

medical-devices
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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

Biologics

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medical-devices
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Eye Doctor Emerges as Contender for CBER Head

FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBER’s next director.

medical-devices
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FDA rejects Replimune Melanoma Therapy Again

FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for ad...

medical-devices
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Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.

medical-devices
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Positive Phase 3 Date for Subcutaneous Tepezza: Amgen

Amgen reports positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepezza (teprotumumab-tr...

FDA General

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medical-devices
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FDA Lays Out Next Phase of Plan to Reduce Animal Testing

FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modern...

medical-devices
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Collins Presses for Faster Generic Competition at Hearing

U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing ...

medical-devices
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Trump Names Erica Schwartz to Head CDC

The Trump administration nominates former deputy surgeon general Erica Schwartz to be CDC director, and taps FDA principal deputy commissioner Sara Br...

medical-devices
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Kennedy Hearing Repeatedly Raised FDA Actions

A House hearing on HHS’ budget sees lawmakers repeatedly questioning secretary Robert F. Kennedy Jr. on FDA issues, including drug regulation, approva...

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Federal Register

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Padcev-Keytruda Combo for Broader Bladder Cancer

FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortuma...

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FDA Streamlined Compliance Policy for Certain Respirators

FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket...

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Phillips Ventilator Correction is Class 1 Recall

FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recal...

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FDA Updates Compliance Program for Biologic Drug Manufacturers

FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing fac...

Human Drugs

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Trump Signs Executive Order to Accelerate Psychedelic Therapies

President Trump signs an executive order aimed at accelerating the development and availability of p...

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Guidance on Impurity Standards For Fermentation-Based Antibiotics

FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for ant...

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Opna Bio Wins FDA Fast Track for Multiple Myeloma Drug

FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its u...

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White Paper on Improving Accelerated Approval Path

An Institute for Clinical and Economic Review white paper states the potential benefits and challeng...

Marketing

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Will the Push for DTC Pre-Review Grow?

Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congres...

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Alymsys Patient Brochure False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosi...

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Lucemyra Web Site Home Page False or Misleading: FDA

FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucem...

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Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer d...

Medical Devices

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Philips Wins Clearance for AI-powered Spectral CT System

FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as th...

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AdvaMed Recommendations for Class 2 Notification Exemption

AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class...

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Town Hall Discusses QMSR Basics and Answers Questions

An FDA town hall gives a detailed explanation of the new medical device Quality Management System Re...

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Don’t Underestimate Device Quality System Inspection Changes: Column

Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Mana...