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FDA launches a collaboration to develop a Home as a Healthcare Hub prototype to help patients, healthcare providers, and industry.

latest-news

FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

LATEST NEWS

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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, healthcare providers, and industry.

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New Bladder Cancer Therapy Approved

FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

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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 device manufacturing facility in Suzhou, China.

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Get Involved with FDA on AI/ML: Attorneys

Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence and machine learning.

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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”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

medical-devices
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Enlivex Mixed Results of Sepsis Cell Therapy

Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.

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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New Bladder Cancer Therapy Approved

FDA approves an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmet...

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PMRs and PMCs Generally on Schedule: FDA Report

FDA says most applicants completed or released most of the premarketing requirements or commitments ...

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Par Recalls 7 Treprostinil Lots

Endo’s Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential...

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Boxed Warning Ordered on CAR T-Cell Therapies

FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administra...

Marketing

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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...

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Industry Faults FDA Research on DTC ‘Implied Claims’

Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Dru...

Medical Devices

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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...

motusgi
Read More
QS, MDR Issues at Royal Philips China Plant

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

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Read More
Sail Fusion Sacroiliac Fusion Device Cleared

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

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Exactech Recalls Equinoxe Shoulder Devices

Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities’ un...