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FDA commissioner-nominee Marty Makary pledges during his confirmation hearing to do an “independent assessment on personnel” before recommending if any additional staff cuts are warranted at the agency.

latest-news

FDA denies a hearing on Vanda’s Hetlioz sNDA and proceeds with its rejection of the filing.

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Makary Pledges FDA Staff Assessment Due to Firings

FDA commissioner-nominee Marty Makary pledges during his confirmation hearing to do an “independent assessment on personnel” before recommending if any additional staff cuts are warranted at the agency.

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FDA Nixes Vanda Hetlioz Hearing

FDA denies a hearing on Vanda’s Hetlioz sNDA and proceeds with its rejection of the filing.

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Opportunities for Drug Development Dynamic Tools

FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.

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Micro Therapeutics Recalls Embolization Device

Medtronic’s Micro Therapeutics unit recalls its Pipeline Vantage Embolization Device with Shield Technology after it determined that the use of the embolization device may lead to incomplete wall apposition and braid deformation.

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Animal Drugs

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medical-devices
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Indian-Made Generics Have Higher Risk: Study

An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with serious adverse events...

medical-devices
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FDA Clinical Hold on BioNTech Malaria Vaccine

FDA places a clinical hold on BioNTech’s Phase 1/2a dose escalation clinical trial evaluating an investigational RNA-based vaccine (BNT165e) for preve...

medical-devices
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Canine Librela Adverse Events Analyzed: CVM

FDA says it has completed its evaluation of several adverse effects found in dogs treated with Librela for pain associated with osteoarthritis.

medical-devices
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Animal Drug Regs Amended to Reflect Approvals

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related applications.

Biologics

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medical-devices
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FDA OKs Gene Therapy for Retinal Disease

FDA approves a Neurotech Pharmaceuticals BLA for Encelto (revakinagene taroretcel-lwey) for treating macular telangiectasia Type 2 (MacTel), a neurode...

medical-devices
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Roche Files sBLA for Gazyva in Lupus

FDA accepts for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis.

medical-devices
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Celltrion’s Prolia and Xgeva Biosimilars Approved

FDA approves a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgen’s Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgen’s Xge...

medical-devices
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PhRMA Seeks Changes to Protocol Deviations Guide

Pharmaceutical Research and Manufacturers of America says FDA should make sure its recent draft guidance entitled “Protocol Deviations for Clinical In...

FDA General

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medical-devices
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Makary Pledges FDA Staff Assessment Due to Firings

FDA commissioner-nominee Marty Makary pledges during his confirmation hearing to do an “independent assessment on personnel” before recommending if an...

medical-devices
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DOGE-Targeted FDA Lab to Remain Open

The Trump Administration reverses an Elon Musk decision to terminate the lease of a 52,000 square foot major FDA laboratory in St. Louis, MO.

medical-devices
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Makary To Divest Extensive Holdings: Ethics Report

The ethics form submitted to HHS by FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins University upon confirmat...

medical-devices
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Chem-Tech Inspection Violations

FDA warns Pleasantville, IA-based Chem-Tech about CGMP violations in its manufacturing of finished drugs.

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Federal Register

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2 Guides on Cell/Tissue Disease Transmission Delayed

Federal Register notice: FDA delays by three months the effective dates of two final guidances on re...

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Info Collection on Rx Labeling Requirements

Federal Register notice: FDA sends to OMB an information collection revision entitled “Labeling Requ...

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Biosimilar User Fees Info Collection Revised

Federal Register notice: FDA sends to OMB an information collection revision entitled “Biosimilars U...

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Animal Drug Regs Amended for Recent Approvals

Federal Register notice: FDA amends its regulations to reflect recent application-related actions fo...

Human Drugs

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FDA Nixes Vanda Hetlioz Hearing

FDA denies a hearing on Vanda’s Hetlioz sNDA and proceeds with its rejection of the filing.

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Opportunities for Drug Development Dynamic Tools

FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.

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FDA OKs Expanded Use of Furoscix

FDA approves a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the ...

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Orphan Drug Designation for Faron’s Bexmarilimab

FDA grants orphan drug designation to Faron’s bexmarilimab to treat myelodysplastic syndrome.

Marketing

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Capricor BLA for Duchenne-related Cardiomyopathy

FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treat...

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OPDP Hits Edenbridge Pharma Over Promos

CDER's Office of Prescription Drug Promotion sends an untitled letter to Edenbridge Pharmaceuticals ...

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Bipartisan Bill on Influencer, Telehealth Ads

Sens. Durbin and Marshall introduce the Protecting Patients from Deceptive Drug Ads bill to increase...

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Durbin, Grassley Reintroduce Drug Ad Price Bill

A bipartisan group of senators reintroduce legislation to mandate the inclusion of drug prices in di...

Medical Devices

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Micro Therapeutics Recalls Embolization Device

Medtronic’s Micro Therapeutics unit recalls its Pipeline Vantage Embolization Device with Shield Tec...

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2 FDA Designations for Phantom Neuro Platform

FDA approves both Breakthrough Device and Targeted Acceleration Pathway designations for Phantom Neu...

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Nuwellis AquaFlexFlow Recall is Class 1

FDA says a Nuwellis 12/2024 recall of certain lots of its extracorporeal blood circuits is Class 1.

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Baxter Infusion Pump Issue Early Alert

FDA issues a medical device early alert on a Baxter recall of specified Spectrum infusion pumps.