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FDA Oks Prosthetic Joint Infections Study

[ Price : $8.95]

FDA gives the green light to Phaxiam Therapeutics for a Phase 2 study (GLORIA) to evaluate its anti-Staphylococcus aureus phages i...

Journey Rosacea Drug Approved by FDA

[ Price : $8.95]

FDA approves a Journey Medical NDA for Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for treating rosacea in...

Percussionaire Recalls Breathing Circuits

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Percussionaire recalls certain lots of its Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one ...

Opioid REMS to Require Mail-Back Envelopes

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FDA approves the addition of mail-back envelopes to the existing opioid analgesic risk evaluation and mitigation strategy to help ...

FDA Taps Comstock Rick for Rare Disease Hub

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FDA brings on former Leavitt Partners consultant Amy Comstock Rick to serve as strategic coalitions director for the newly created...

Aarti Drugs India Plant Hit with FDA-483

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A recent inspection of Aarti Drugs Ltds active pharmaceutical ingredient manufacturing plant in India leads to a seven-item FDA Fo...

Sen. Rubio Seeks to Ban Certain APIs from China

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Senator Marco Rubio (R-FL) urges FDA to take immediate action against two pharmaceutical companies based in Chinas Xinjiang region...

Panel Rejects Lexicon Pharma Diabetes Drug

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A FDA advisory committee votes against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) for adult...

FDA Reconsiders CAR-T Product Warning: Marks

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FDA backpedals on safety warnings it required on CAR-T cell therapies related to secondary cancers, according to CBER director Pet...

Court Backs FDA Lumryz Approval

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The DC federal court tosses a Jazz Pharmaceuticals suit against FDA over the agencys approval of Avadels narcolepsy drug Lumryz be...