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Complete Response Letters to be Posted in Real Time: FDA

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

Breakthrough Status for AI Prostate Treatment Planner

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

Milestone Pharma Resubmits Cardamyst NDA

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

Access to Care House Hearing Set

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

Broselow Pediatric Emergency Rainbow Tape Recall

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AirLife recalls certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect inform...

Avanos Recalls Ventilator Suction Devices

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

FDA Publishes Complete Response Letters

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

Makary Touts Successes in 1st Hundred Days

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

Merck NDA Accepted for HIV Combination Therapy

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FDA accepts for review a Merck NDA for its investigational once-daily HIV treatment combining doravirine and islatravir.

Senate Committee Advances FDA Budget Bill

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The Senate Committee on Appropriations votes to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Develo...