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Biologics

Explain FDA Vaccine Approval Process: Study

The Annenberg Public Policy Center recommends steps to reduce misinformation about the RSV vaccine and promote its use by pregnant women when one is a...

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Human Drugs

FDA Approves Janssens Talvey

FDA gives accelerated approval to Janssens Talvey to treat some adult multiple myeloma patients.

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Human Drugs

Underrepresented Population Data Guidance

FDA publishes a draft guidance on obtaining postmarketing safety and effectiveness information on drugs in historically underrepresented patient popul...

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Medical Devices

FDA Updates Regulatory Science Device Catalog

FDA adds four new and updates nine existing tools in its medical device regulatory science tools catalog.

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Medical Devices

Cardiosave Intra-aortic Balloon Pumps Recalled

Datascope/Maquet/Getinge recalls the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps because they may shutdown without warning due to electric...

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Medical Devices

Accurays VitalHold for Breast Cancer Cleared

FDA clears an Accuray 510(k) for its VitalHold breast cancer package and its use on the companys Radixact radiation therapy system.

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Medical Devices

ZimVies Smaller Mobi-C Cervical Disc OKd

FDA approves a ZimVie PMA supplement for a smaller height of its Mobi-C Cervical Disc in seven sizes to address the anatomical needs of diverse patien...

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Biologics

Biosimilar Formal Meetings Draft Guide

FDA posts a draft guidance on biosimilar development formal meetings between the agency and sponsors.

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Human Drugs

PhRMA, Others Boost FDA Discussion Paper on AI

PhRMA tells FDA it strongly agrees with the potential benefits of artificial intelligence and machine learning, among three other public commenters vi...

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Human Drugs

Novartis Reports Positive Data on Remibrutinib

Novartis says top-line data from two Phase 3 studies evaluating remibrutinib 25 mg in patients with chronic spontaneous urticaria met their primary en...