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HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance at security checkpoints at the agency’s White Oak, MD campus.

latest-news

Despite HHS secretary Robert F. Kennedy, Jr.’s promises to boost transparency at HHS and its health agencies, staff cuts now occurring will likely cripple the information and communications offices that many rely on for information and insight into regulatory actions.

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FDA in Upheaval as Staff Layoffs Begin

HHS begins terminating FDA employees, with many receiving email notifications in the early morning hours or being denied entrance at security checkpoints at the agency’s White Oak, MD campus.

motusgi
RFK Jr. Upends His Promise to Enhance Transparency

Despite HHS secretary Robert F. Kennedy, Jr.’s promises to boost transparency at HHS and its health agencies, staff cuts now occurring will likely cripple the information and communications offices that many rely on for information and insight into regulatory actions.

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FDA Says Rex Implants Illegally Marketing Devices

FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three medical devices.

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Multiple Violations in Next Science Inspection

FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing adulterated and misbranded medical devices that have Quality System and Medical Device Reporting violations.

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Animal Drugs

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medical-devices
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AstraZeneca Touts New Tagrisso Data

AstraZeneca says new study data on Tagrisso (osimertinib) show an “improved overall survival trend” in certain patients with non-small cell lung cance...

medical-devices
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Alnylam Gets Additional Approval for Amvuttra

FDA approves an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin amyloidosis with ca...

medical-devices
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Pancreatic Cancer Drug Gets Orphan Status

FDA awards PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer.

medical-devices
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FDA Outlines Concerns with Unapproved GLP-1 Drugs

FDA posts its concerns with unapproved GLP-1 drugs used for weight loss.

Biologics

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medical-devices
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Marks’ Firing Challenges RFK Jr.’s Fitness for Office

FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and vaccine skeptic Robert...

medical-devices
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Smallpox/Mpox Vaccine OK’d Despite CBER Turmoil

FDA approves Bavarian Nordic’s freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Peter Marks’ departur...

medical-devices
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Advocates Blast Hiring ‘Quack’ for Autism Study

The Autism Self-Advocacy Network sharply criticizes HHS for hiring “quack” David Geier to study a potential link between autism and vaccines, which th...

medical-devices
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Rybrevant Beats Tagrisso in Head-to-Head Trial: J&J

Johnson & Johnson says Rybrevant outperformed AstraZeneca’s Tagrisso in a head-to-head study in the first-line treatment of patients with locally adva...

FDA General

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medical-devices
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RFK Jr. Upends His Promise to Enhance Transparency

Despite HHS secretary Robert F. Kennedy, Jr.’s promises to boost transparency at HHS and its health agencies, staff cuts now occurring will likely cri...

medical-devices
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Trump Order Stifles Union Representation at FDA

President Trump signs an executive order to remove organized union representation from the majority of government agencies, including FDA, to make it ...

medical-devices
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FDA to Cut Another 3,500 Employees Under HHS Plan

HHS says FDA will lose about 3,500 (18%) of its 19,000 full-time employees under a just-announced “reductions in force” plan to consolidate activities...

medical-devices
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Makary Wins Senate Floor Vote on FDA Confirmation

A Senate floor vote moves Marty Makary one step closer to becoming the next FDA commissioner.

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Federal Register

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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...

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Device Consensus Standards Publication

Federal Register notice: FDA updates its publication on modifications to the list of recognized cons...

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FDA Withdraws Sage’s NDA for Zulresso

Federal Register notice: FDA withdraws the approval of a Sage Therapeutics NDA for Zulresso (brexano...

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Garmendia Permanently Debarred Over Trial Fraud

Federal Register notice: FDA rejects a request for a hearing submitted by Bernardo Garmendia, and is...

Human Drugs

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FDA in Upheaval as Staff Layoffs Begin

HHS begins terminating FDA employees, with many receiving email notifications in the early morning h...

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Axsome Solriamfetol Misses Primary Endpoint

Axsome Therapeutics says its solriamfetol missed the primary endpoint in a Phase 3 proof-of-concept ...

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Compass Therapeutics Reports on Tovecimig Trial Data

Compass Therapeutics reports statistically significant top-line data on the primary efficacy endpoin...

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3 Observations on SKNV Outsourcing FDA-483

FDA releases the form FDA-483 with three observations from an inspection at the Pompano Beach, FL-ba...

Marketing

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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...

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OPDP Hits Edenbridge Pharma Over Promos

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

Medical Devices

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FDA Says Rex Implants Illegally Marketing Devices

FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three ...

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Multiple Violations in Next Science Inspection

FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing ad...

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Bausch + Lomb Recalls enVista Intraocular Lenses

Bausch + Lomb recalls all enVista intraocular lenses due to increasing adverse event reports of toxi...

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FDA Clears TrainHealth’s Neuromuscular Stimulator

FDA clears a TrainHealth 510(k) for its TrainFES neuromuscular stimulator and its use in treating pe...