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Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization.

latest-news

FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubrutinib) misbrands the drug.

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Pazdur Warns About Political Interference, Upheaval At FDA

Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization.

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FDA Cites Cancer Drug Television Ad

FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubrutinib) misbrands the drug.

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Remove Suicide Warning from GLP-1 Drugs: FDA

FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for their weight loss drugs Saxenda, Wegovy, and Zepbound, following an agency comprehensive evaluation that found no association.

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Ways for FDA to Modernize Biotech Regulation

The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regulation.

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Animal Drugs

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medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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medical-devices
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35 Items on CDER CY2026 Guidance Agenda

CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draft guidances on aspec...

medical-devices
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PharmaEssentia Besremi sBLA for Essential Thrombocythemia.

FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...

medical-devices
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Flexible Regulatory Approaches for Cell/Gene Therapy CMC Info

FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the agency says is intende...

medical-devices
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FDA 2nd Complete Response on BLA for Atara Cell Therapy

FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics’ investigational cell therapy fo...

FDA General

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medical-devices
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Pazdur Warns About Political Interference, Upheaval At FDA

Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agency’s abi...

medical-devices
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Harvard Law Hits User Fees Over ‘Corporate Capture’

A new analysis from Harvard Law School argues that the U.S. drug regulator’s reliance on industry-paid user fees has left the agency vulnerable to bot...

medical-devices
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End-of-December Warning Letters

FDA releases substantive Warning Letters in the last two weeks of December 2025.

medical-devices
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FDA Tumult Keeps Makary Under Microscope: NYT Article

The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

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

Human Drugs

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FDA Cites Cancer Drug Television Ad

FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television...

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Remove Suicide Warning from GLP-1 Drugs: FDA

FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation a...

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FDA Extends Review for Filspari in Kidney Disease

FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in fo...

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CGMP Violation at India’s Chemspec Chemicals

FDA warns India’s Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceut...

Marketing

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

Medical Devices

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AVID Medical Recalls Organ Recovery Bags

AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits...

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RWE, 510(k) TTD Discussed in MDUFA 6 Reauthorization

At a 12/11/2025 MDUFA 6 reauthorization meeting, FDA presented its views on changes involving using ...

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Two Digital Health Guidances Published

FDA publishes digital health guidances relating to low-risk general wellness products and clinical d...

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Dexcom Glucose Monitor Software Correction is Class 1

FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous gluco...