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5 CGMP Issues Cited in Ross Healthcare Inspection

FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.

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Fresenius Recalls Ivenix Pumps Over Software Issue

Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.

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FDA Division of Applied Regulatory Science Releases Annual Report

CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advances, collaborative scientific efforts, and regulatory science initiatives aimed at improving public health and regulatory decision-making.

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Rep. Gottheimer Introduces 5 Bipartisan Rare Disease Bills

Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.

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Animal Drugs

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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

medical-devices
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Sangamo Begins Rolling BLA for Fabry Gene Therapy

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following result...

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.

Biologics

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medical-devices
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FDA Accepts Vanda BLA for Rare Skin Disorder Drug

FDA accepts for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis.

medical-devices
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BioMarin Withdrawing Hemophilia A Gene Therapy

BioMarin decides to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe ...

medical-devices
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J&J Files sBLA for Imaavy in Rare Anemia

Johnson & Johnson files a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia.

medical-devices
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FDA Flip Flops; Agrees to Now Review Moderna Vaccine

FDA reverses course and agrees to review Moderna’s seasonal influenza mRNA vaccine after previously refusing to file the BLA.

FDA General

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medical-devices
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Makary Defends Approval Standards and Prasad’s Role

FDA commissioner Marty Makary defends the agency’s scientific standards and personnel, particularly CBER Director Vinay Prasad, amid mounting politica...

medical-devices
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JAMA Examines FDA’s Move Away From Advisory Committees

A new JAMA Health Forum analysis examines FDA’s shift in how it seeks outside scientific advice while shunning advisory committee meetings, raising le...

medical-devices
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Trust in FDA and CDC Remains Low After Vaccine Changes

A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to the federally recomme...

medical-devices
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FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO

A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reducti...

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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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5 CGMP Issues Cited in Ross Healthcare Inspection

FDA warns Ross Healthcare, in Lynden, WA, about CGMP violations in its production of finished drugs.

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FDA Division of Applied Regulatory Science Releases Annual Report

CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlightin...

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Read More
Rep. Gottheimer Introduces 5 Bipartisan Rare Disease Bills

Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.

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CDER Plans 81 New, Revised Guidances in 2026

FDA releases a list of 81 new and revised guidances in 12 categories that CDER plans to issue this c...

Marketing

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

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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...

Medical Devices

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Fresenius Recalls Ivenix Pumps Over Software Issue

Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.

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Alert on Abiomed Heart Pumps

FDA issues an early alert about a potentially high-risk problem involving certain heart pump compone...

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AdvaMed Presses FDA to Anchor Federal Strategy on Clinical AI

AdvaMed urges federal health officials to keep FDA at the center of oversight for artificial intelli...

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Olympus Recalls High-Flow Insufflation Units

Olympus recalls its high-flow insufflation units, warning that continued use of the devices could ca...