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The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefit to using fenofibrates alone or with statins.

latest-news

Sen. Bernie Sanders and the HELP Committee call on Novo Nordisk to significantly reduce the cost of its Ozempic and Wegovy in the U.S.

LATEST NEWS

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State Lack of Fenofibrate CV Benefit: Petition

The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is no proven cardiovascular benefit to using fenofibrates alone or with statins.

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Cut Ozempic/Wegovy Price: HELP Committee

Sen. Bernie Sanders and the HELP Committee call on Novo Nordisk to significantly reduce the cost of its Ozempic and Wegovy in the U.S.

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Zydus Lifesciences Issued Another FDA-483

An FDA inspection at Zydus Lifesciences’ injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, the second received by the company in the past month.

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Curio Postpartum Depression Device Cleared

FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression.

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Animal Drugs

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medical-devices
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Pediatric Brain Tumor Therapy Approved

FDA grants Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age an...

medical-devices
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Guide on Animal Drug Mfg. Batches

FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

medical-devices
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2 Veterinary Medicine Guidances Published

The Center for Veterinary Medicine issues two guidances on data element submission.

medical-devices
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Animal Drug API GMP Guidance

FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for animal drug APIs.

Biologics

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medical-devices
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Priority Review for Jemperli sBLA

FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...

medical-devices
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‘Complete Response' on Abeona’s PZ-Cel BLA

FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...

medical-devices
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Alvotech/Teva’s Stelara Biosimilar Approved

FDA approves Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson & Johnson’s Stelar...

medical-devices
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GSK BLA Accepted for Meningococcal Vaccine

FDA accepts for review a GSK BLA for its 5-in-1 meningococcal ABCWY vaccine candidate.

FDA General

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medical-devices
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Califf in Hot Seat at 4/11 Oversight Hearing

The House Committee on Oversight and Accountability ratchets up political pressure on FDA by requesting commissioner Robert Califf’s testimony at a 4/...

medical-devices
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Poll Backs FDA Status Quo in Approving Products

In the wake of this week’s U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that most Americans say t...

medical-devices
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Weiner Moves to Foreign Inspections Office

FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where he will oversee the ...

medical-devices
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GAO Report Hits FDA on Investigator Retention

A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigato...

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Federal Register

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23 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they...

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Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available its annual report entitled “Report on the Performance o...

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Colon Cancer Blood Test Goes to Panel

Federal Register notice: An FDA advisory committee schedules a 5/23 meeting to review a Guardant Hea...

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Info Collection on FDA Social/Behavioral Research

Federal Register notice: FDA seeks comments on an information collection extension entitled “Data To...

Human Drugs

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State Lack of Fenofibrate CV Benefit: Petition

The educational group Healthy Women petitions FDA to change fenofibrate labeling to state there is n...

motusgi
Read More
Cut Ozempic/Wegovy Price: HELP Committee

Sen. Bernie Sanders and the HELP Committee call on Novo Nordisk to significantly reduce the cost of ...

motusgi
Read More
Zydus Lifesciences Issued Another FDA-483

An FDA inspection at Zydus Lifesciences’ injectable manufacturing site in Jarod, India results in a ...

motusgi
Read More
Boehringer on Improving Informed Consent Guide

Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and ...

Marketing

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Biological Promotion Q&A Guidance

FDA publishes a draft guidance with questions and answers on promotional communications for some pre...

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Methodological Rigor Info May Help Promotions: OPDP

CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in commun...

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Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and ...

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Digital Drug Marketing Workshop Themes

A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital...

Medical Devices

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Curio Postpartum Depression Device Cleared

FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therape...

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FDA Launches ‘Home as a Healthcare Hub’

FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healt...

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Sail Fusion Sacroiliac Fusion Device Cleared

FDA clears a Sail Fusion 510(k) for its BowTie Sacroiliac Fusion System.

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QS, MDR Issues at Royal Philips China Plant

FDA warns Royal Philips about Quality System and Medical Device Reporting violations at its medical ...