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HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activist David Geier at the Department.

latest-news

Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariatric surgery in a pivotal Phase 3 clinical trial.

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RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activist David Geier at the Department.

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Lilly Says Retatrutide Delivered Up to 30% Weight Loss

Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariatric surgery in a pivotal Phase 3 clinical trial.

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FDA to Convene Panel on Moderna’s mRNA Flu Vaccine

FDA announces a 6/18 advisory committee meeting to review Moderna’s controversial mRNA-based seasonal influenza vaccine.

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Clarity Sought on FDA New Approach Methodologies Guide

Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.

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Animal Drugs

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medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

medical-devices
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White House Reportedly Moves to Oust Commissioner Makary

Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

medical-devices
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Atara says FDA outlined potential path for Cell Therapy Resubmission

Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...

Biologics

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medical-devices
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RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activis...

medical-devices
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FDA to Convene Panel on Moderna’s mRNA Flu Vaccine

FDA announces a 6/18 advisory committee meeting to review Moderna’s controversial mRNA-based seasonal influenza vaccine.

medical-devices
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FDA Has to Build CRISPR Edit Review Protocol

A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to addre...

medical-devices
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ImmunityBio’s Anktiva sBLA for Expanded Use Accepted by FDA

FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with...

FDA General

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medical-devices
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Will the Next Commissioner Learn from Makary’s Mistakes?

Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and...

medical-devices
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Health Affairs Commentary Says Makary Left FDA ‘Weaker’

Two prominent drug-policy scholars sharply criticize former FDA commissioner Marty Makary in a Health Affairs commentary, arguing that his tenure weak...

medical-devices
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More FDA Turmoil: Drug, Biologics Leaders Removed

FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.

medical-devices
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FDA May be OK Under Loper Bright: Article

University of Missouri law professor Erika Lietzan says FDA may not suffer as much under the Supreme Court’s Loper Bright decision as policy analysts ...

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Federal Register

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

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Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its ro...

Human Drugs

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Lilly Says Retatrutide Delivered Up to 30% Weight Loss

Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results a...

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Clarity Sought on FDA New Approach Methodologies Guide

Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in ...

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Comments on Increasing Access to Non-Prescription Drugs

Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.

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Clinical Electronic Structured Protocol Template

FDA publishes for reference only an International Council for Harmonization template on a clinical e...

Marketing

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DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

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Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

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Advertising Experts Critique FDA’s Increasing Enforcement

Pharmaceutical advertising experts react to FDA’s dramatically altered enforcement approach toward p...

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Nubeqa TV Ad, Video Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa ...

Medical Devices

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Bolton Thoracic Stent Recall is Class 1: FDA

FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.

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React Health Recalls Ventilators Due to Manufacturing Issue

React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to...

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Implantica Submits Final FDA Response for RefluxStop PMA

Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agency’s rem...

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Valar Labs Wins Breakthrough Status for AI Bladder Cancer Test

FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.