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More Hemodialysis Toxic Compound Analysis Needed: FDA

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FDA says it is working with additional manufacturers of hemodialysis and peritoneal dialysis systems to determine the potential ri...

FDA Grants De Novo Device for Tinnitus

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FDA grants Neuromod Devices a de novo request to market Lenire, the first bimodal neuromodulation device for treating tinnitus.

Aclaris Skin Condition Study Misses Endpoint

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Aclaris Therapeutics says a Phase 2 clinical study investigating the efficacy and safety of zunsemetinib in treating hidradenitis ...

Some Guidance Changes Helpful, More Needed: AAM

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The Association for Accessible Medicines urges FDA to continue to revise a draft guidance on pre-submission facility correspondenc...

Dupixent sBLA for Chronic Spontaneous Urticaria

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FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents a...

Questions on Oncologic Investigational Agent Guidance

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The National Cancer Institute raises concerns about an FDA guidance that requires studies of oncologic investigational agents to e...

Priority for Alzheimers sBLA Seeking Traditional Approval

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FDA accepts for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is inte...

DoJ Preferring Deferred Prosecution Agreements: Attorneys

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Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more Department of Justice deferred...

Panel to Weigh OTC Phenylephrine Efficacy

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FDA announces a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-...

Incyte Abandons Phase 3 Myelofibrosis Trial

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An unfavorable interim analysis leads Incyte to discontinue the Phase 3 LIMBER-304 myelofibrosis trial due to efficacy concerns.