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Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

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Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung cancer.

LATEST NEWS

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FDA Seeks Post-Marketing Commitment from Novavax

Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

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Akeso’s Ivonescimab Meets Endpoint in Lung Cancer

Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung cancer.

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Update Drug Labels with Obesity Info: Pitts

Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness information.

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Lilly Sues 4 More Weight-Loss Drug Compounders

Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.

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Animal Drugs

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medical-devices
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Inspections Will Suffer Under FDA Cuts: Lawyers

Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...

medical-devices
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Self-Inject Vyvgart Hytrulo Approved

FDA approves an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) f...

medical-devices
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Rhythm Pharma ‘Positive’ Data on Obesity Drug

Rhythm Pharmaceuticals announces “positive topline results” from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for treating acquired hy...

medical-devices
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Amgen’s Uplizna OK’d for Immunoglobulin G4 Disease

FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease.

Biologics

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medical-devices
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FDA Seeks Post-Marketing Commitment from Novavax

Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

medical-devices
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Celltrion’s Humira Biosimilar Now Interchangeable: FDA

FDA grants interchangeable biosimilar status to Celltrion’s Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVie’s Humira.

medical-devices
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Marks Warns of Growing Anti-Vaccine Stance

Former CBER director Peter Marks tells Time that he was seeing “an increasing anti-vaccine tone” before he resigned from the agency over pressure from...

medical-devices
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Fast Track for H5N1 Flu mRNA Vaccine

FDA grants Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, for protecting against H5N1 influ...

FDA General

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medical-devices
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ESG NextGen is Live: FDA

FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.

medical-devices
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Lt. Governors Urge Trump to Support FDA, Other Agencies

The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of key federal science...

medical-devices
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FDA Integrity, Decision-Making at Risk: Blog

FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need to decide whether th...

medical-devices
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AI in Regulatory Science: Conference Report

A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...

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Federal Register

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

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Panel on Opioid Overdose Studies

Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involvi...

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House Committee Hearing on Reducing FDA Inefficiencies

The U.S. House Committee on Oversight and Government Reform announces a 4/9 hearing on reducing inef...

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FDA Revokes EUAs on 3 Beckman Coulter Tests

Federal Register notice: FDA revokes Emergency Use Authorizations issued to Beckman Coulter for thre...

Human Drugs

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Akeso’s Ivonescimab Meets Endpoint in Lung Cancer

Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line tr...

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Update Drug Labels with Obesity Info: Pitts

Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity...

motusgi
Read More
Lilly Sues 4 More Weight-Loss Drug Compounders

Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diab...

motusgi
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Vanda Criticizes FDA on Tradipitant Hearing Delay

Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissio...

Marketing

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Drug Promotion Leaders Leave Agency

FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine re...

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Lytgobi Web Page False, Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy pre...

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Plus Therapeutics Gets Orphan Statis for Radiotherapy

FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiothera...

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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...

Medical Devices

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Alert Issued on Conavi’s Novasight Catheters

The catheter is part of a system intended for intravascular imaging of coronary arteries.

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CereVasc Gains Breakthrough Status for eShunt

FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its ...

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QS Violations at Noah Medical Corporation

FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of th...

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ICU Medical Illegally Marketing Devices: FDA

FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing ...