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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...

FDA Approves Moderna Covid Vaccine sBLA

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

Rhythm Reports Positive Data on Obesity Drug

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

Exactech Equinoxe Scapula Reconstruction Device Cleared

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

FDA Mifepristone Restrictions are Legal: Judge

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A Washington federal judge says FDA acted lawfully in imposing restrictions on the availability of chemical abortion drugs mifepri...

AirLife/Vyaire Recall Infant Heated Wire Circuits

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AirLife and Vyaire recall certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconne...

Trethera Gets Fast Track for Prostate Cancer Drug

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FDA grants Trethera a fast track designation for TRE-515 for treating prostate cancer.