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Lawyer Says Not Enough FDA Digital Health Standards

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Attorney Bradley Thompson says he is surprised and disappointed that FDA is not approving enough new consensus standards to suppor...

Pilot Evaluating Quicker Reviews for Some Drugs

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FDA announces a pilot program designed to expedite the review of new therapies addressing unmet medical needs.

Clinical Holds Lifted on 3 CARsgen Cell Products

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FDA removes the clinical holds on three CARsgen Therapeutics clinical trials evaluating CT053, CT041, and CT071.

Phase 3 Study on Disc Medicines Bitopertin

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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

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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...