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FDA lifts a partial clinical hold on Avidity Biosciences’ delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for treating myotonic dystrophy Type 1.

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FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provell’s Euthyrox (levothyroxine sodium).

LATEST NEWS

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FDA Lifts Hold on Myotonic Dystrophy Drug

FDA lifts a partial clinical hold on Avidity Biosciences’ delpacibart etedesiran (del-desiran/AOC 1001) that is being evaluated for treating myotonic dystrophy Type 1.

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FDA Denies Amneal Levothyroxine Petition

FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provell’s Euthyrox (levothyroxine sodium).

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Tirzepatide Shortage ‘Resolved,’ FDA Says

FDA says the shortage of Lilly’s Mounjaro and Zepbound has been resolved but other similar products remain in short supply.

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OrthAlign’s Lantern Hip Handheld Naviation Cleared

FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in the supine position.

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Animal Drugs

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medical-devices
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Elanco Gets Anti-Itch Zenrelia Approved for Dogs

FDA approves Elanco Animal Health’s Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associated with allergic ...

medical-devices
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CVM Draft Guide on CMC Technical Section

FDA releases a CVM draft guidance entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.”

medical-devices
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FDA Publishes 2 Revised VICH Guidances

FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures for veterinary drugs.

medical-devices
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VICH Residual Solvents Guidance

FDA publishes a Veterinary International Conference on Harmonization revised guidance on residual solvents used in animal drugs.

Biologics

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medical-devices
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Stem Cell Company CEO Gets 36 Months in Jail

The Justice Department says Liveyon founder and CEO John Kosolcharoen has been sentenced to 36 months in prison after pleading guilty to one count of ...

medical-devices
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Fresenius/Formycon Stelara Biosimilar Approved

FDA approves Fresenius Kabi and Formycon’s biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnson’s referenced Stelara.

medical-devices
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J&J Files sBLA for Darzalex Faspro

Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication — combination use with bortez...

medical-devices
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Appeals Court Gives FDA a Win on Stem Cells

The U.S. 9th Circuit Court of Appeals reverses an earlier California lower court decision that ruled a stem cell treatment firm is exempt from FDA reg...

FDA General

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medical-devices
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FDA Inspections Reorganization Effective 10/1

FDA begins implementing a new model for FDA inspections as part of an agency-wide reorganization that was brought on by the 2022 infant formula debacl...

medical-devices
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FDA Discusses Optimizing Advisory Committees

FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advice received from adv...

medical-devices
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RFK Jr. to Recommend Trump Health Agency Heads?

Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people to run FDA and other...

medical-devices
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Advisors Surveyed on Committee Reforms

3D Communications shares the results from its survey of FDA advisory committee members on committee reform issues.

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Federal Register

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Guide on Study E-Records/Signatures

Federal Register notice: FDA makes available a final guidance entitled “Electronic Systems, Electro...

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Augmentin Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that U.S. Antibiotics’ Augmentin XR (amoxicillin; clavulanat...

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Panel to Review Andexxa sBLA

Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Commit...

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Lexicon Diabetes Drug Heads to Panel

Federal Register notice: FDA announces that a 10/31 Endocrinologic and Metabolic Drugs Advisory Comm...

Human Drugs

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FDA Lifts Hold on Myotonic Dystrophy Drug

FDA lifts a partial clinical hold on Avidity Biosciences’ delpacibart etedesiran (del-desiran/AOC 10...

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Read More
FDA Denies Amneal Levothyroxine Petition

FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Pr...

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Tirzepatide Shortage ‘Resolved,’ FDA Says

FDA says the shortage of Lilly’s Mounjaro and Zepbound has been resolved but other similar products ...

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5 Observations on BSO FDA-483

FDA has released the form FDA-483 with five observations from an inspection at the Lakewood, CO-base...

Marketing

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FDA to Study Drug Promotion in Talk Shows

The CDER Office of Prescription Drug Promotion says it will research how using an endorser to provid...

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FDA Pushed to Regulate Online Drug Promos

Gardner Law says prescription drug manufacturers and marketers need to be sure their social media pr...

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FDA to Survey Healthcare Providers

The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers o...

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Enforce Regulation of ‘Wellness’ Devices: Petition

Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensu...

Medical Devices

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OrthAlign’s Lantern Hip Handheld Naviation Cleared

FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip...

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Lab Groups Seek Summary Judgment in LDT Suit

Two trade associations that oppose FDA regulation of laboratory-developed tests ask a Texas federal ...

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Philips Respironics Software Correction Class 1: FDA

FDA says a Philips Respironics software correction for several ventilators was a Class 1 recall.

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Siemens PMA for 3D Mammography Platform OK’d

FDA approves a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging te...