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FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff were cut 4/1 under HHS’s mass firings.

latest-news

Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and staff reduction that is underway and be able to do more with less.

LATEST NEWS

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FDA Remaking Inspection Priorities in Wake of Trump Cuts

FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff were cut 4/1 under HHS’s mass firings.

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Can FDA “Do More With Less?”: McClellan

Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and staff reduction that is underway and be able to do more with less.

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FDA Misses Novavax Covid Vaccine Review Action

FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.

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Industry Sounds the Alarm on FDA Staff Cuts

Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews and approvals.

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Animal Drugs

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medical-devices
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Industry Sounds the Alarm on FDA Staff Cuts

Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews and approvals.

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.

Biologics

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medical-devices
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FDA Misses Novavax Covid Vaccine Review Action

FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.

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...

FDA General

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medical-devices
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FDA Remaking Inspection Priorities in Wake of Trump Cuts

FDA says it is reprioritizing planned inspections for the rest of the year due to challenges it faces after 170 administrative and management staff we...

medical-devices
Read More
Can FDA “Do More With Less?”: McClellan

Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and staff reduction that ...

medical-devices
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RFK Jr. Invited to Senate Hearing on HHS Reorganization

The Senate HELP Committee invites HHS secretary RFK, Jr., to testify on his reorganization of the department.

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...

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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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Positive EDG-7500 Heart Drug Phase 2 Results

Edgewise Therapeutics says its EDG-7500 achieved positive results in the four-week CIRRUS-HCM trial ...

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Biogen Gets Fast Track for Alzheimer’s Therapy

Biogen wins a fast-track designation for BIIB080, an investigational antisense oligonucleotide thera...

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Ocrevus IV Phase 3 Study Misses Primary Endpoint

Roche says the Phase 3 MUSETTE study found that a higher dose of Ocrevus IV did not provide more ben...

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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 ...

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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Medivis Spinal Navigation Device Cleared

FDA clears a Medivis 510(k) for its Spine Navigation platform that uses augmented reality and artifi...

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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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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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Multiple Violations in Next Science Inspection

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