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Phase 3 Study on Disc Medicines Bitopertin

[ Price : $8.95]

FDA agrees on a Phase 3 study design for Disc Medicines bitopertin and its use in treating a rare sunlight sensitivity disorder.

Quanta Dialysis Home Dialysis Device Cleared

[ Price : $8.95]

FDA clears a Quanta Dialysis Technologies 510(k) for the use of its Quanta Dialysis System in the home setting.

Mark Cubans Generic Operation Hit with 483

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Mark Cubans Cost-Plus Manufacturing and Compounding facility in Dallas, TX, receives a Form FDA-483 based on findings from a recen...

Ionis NDA for Hereditary Angioedema Attacks

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FDA accepts for review an Ionis Pharmaceuticals NDA for donidalorsen, an RNA-targeted treatment for preventing hereditary angioede...

FDA Oks Prosthetic Joint Infections Study

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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

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

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...

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 ...