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Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over the coming months as about 600 reviewers have currently recused themselves from working on product evaluations while they look for employment outside of the federal government.

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HHS secretary Robert F. Kennedy Jr. vows to restore FDA’s and other health agencies’ Freedom of Information Act (FOIA) offices that were gutted earlier this month under White House-mandated staff cuts.

LATEST NEWS

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An FDA Reviewer Exodus on the Horizon: Gottlieb

Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over the coming months as about 600 reviewers have currently recused themselves from working on product evaluations while they look for employment outside of the federal government.

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RFK Jr. Restoring FDA’s Freedom of Information Office

HHS secretary Robert F. Kennedy Jr. vows to restore FDA’s and other health agencies’ Freedom of Information Act (FOIA) offices that were gutted earlier this month under White House-mandated staff cuts.

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Texas Court Gives FDA Win in Compounding Enforcement

A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforcement actions against compounding pharmacies that make copies of Novo Nordisk’s semaglutide.

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Breakthrough Status for Blood Pressure Therapy

FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pacemaker to reduce blood pressure in patients with increased 10-year atherosclerotic cardiovascular disease risk.

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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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One-Third of Biosimilars Approved Not Launched: Report

A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far only 48 (66%) of these...

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...

FDA General

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medical-devices
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RFK Jr. Restoring FDA’s Freedom of Information Office

HHS secretary Robert F. Kennedy Jr. vows to restore FDA’s and other health agencies’ Freedom of Information Act (FOIA) offices that were gutted earlie...

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...

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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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An FDA Reviewer Exodus on the Horizon: Gottlieb

Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over th...

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Texas Court Gives FDA Win in Compounding Enforcement

A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Asso...

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FDA Clinical Hold on VYNE’s Psoriasis Drug

FDA issues a clinical hold on VYNE Therapeutics’ Phase 1b study evaluating VYN202 for treating moder...

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Staff Cuts Lead to Drug Data Gaps: Sources

Axios reports that key FDA databases that are relied on by healthcare professionals are not being fu...

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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Breakthrough Status for Blood Pressure Therapy

FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modu...

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Abbott Recalls HeartMate Power Units

Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the de...

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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 ...