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Human Drugs

Intuitive Vessel Sealer Cleared for da Vinci Devices

FDA clears an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems.

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Biologics

Interchangeable Biosimilar Product Development Workshop

FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidan...

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Human Drugs

Complete Response Letters to be Posted in Real Time: FDA

FDA commissioner Marty Makary pledges to release new complete response letters in real time.

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Medical Devices

Breakthrough Status for AI Prostate Treatment Planner

FDA grants Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool to help treat patients with local...

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Human Drugs

Milestone Pharma Resubmits Cardamyst NDA

FDA accepts for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered treatment for paroxysma...

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Human Drugs

Access to Care House Hearing Set

The House Energy and Commerce Health Subcommittee schedules a 7/16 hearing on preserving access to timely and affordable care.

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Medical Devices

Broselow Pediatric Emergency Rainbow Tape Recall

AirLife recalls certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect information on the device.

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Human Drugs

Avanos Recalls Ventilator Suction Devices

Avanos Medical recalls its Ballard Closed Suction Systems due to sterilization concerns.

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Human Drugs

FDA Publishes Complete Response Letters

FDA publishes redacted versions of over 200 complete response letters issued between 2020 and 2024 in a demonstration of its commitment to radical tra...

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FDA General

Makary Touts Successes in 1st Hundred Days

FDA commissioner Martin Makary takes a 100-days-in-office victory lap, citing 32 initiatives that he says have been started to Make America Healthy Ag...