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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...

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Human Drugs

Merck NDA Accepted for HIV Combination Therapy

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

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FDA General

Senate Committee Advances FDA Budget Bill

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

Biologics

FDA Approves Moderna Covid Vaccine sBLA

FDA approves a Moderna sBLA for its Spikevax Covid-19 vaccine for children aged six months to 11 years old who are at increased risk for Covid-19.

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Human Drugs

Rhythm Reports Positive Data on Obesity Drug

Rhythm Pharmaceuticals reports positive topline results from its Phase 2 trial evaluating bivamelagon in patients with acquired hypothalamic obesity.

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Medical Devices

Exactech Equinoxe Scapula Reconstruction Device Cleared

FDA clears an Exactech 510(k) for the Equinoxe Scapula Reconstruction System for treating acromial and scapular spine fractures.