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Reviewers Question Otsuka PTSD Drug Efficacy

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FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTS...

Partial Hold on Kezars Zetomipzomib Lifted

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FDA lifts a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomip...

Caranx AI Valve Replacement Software Cleared

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FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operativ...

Sandoz Recalls Mislabeled Cefazolin for Injection

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Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer compla...

HHS Finalizes FDA Employee Terminations

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HHS notifies over 3,000 FDA employees that their employment has been officially terminated effective 7/14.

CGMP Violations Cited in Daewoo Warning

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FDA warns South Koreas Daewoo Pharmaceutical Co. about CGMP violations in its production of finished drugs.

FDA Inspection Backlog Can Hurt Canada: Analysis

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A Benefits Pensions Monitor report says FDA drug inspection backlogs can hurt Canada since FDA has been performing 70% of Canadas ...

Ocular Toxicity Concerns with Multiple Myeloma Drug: FDA

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FDA reviewers plan to ask an advisory committee this week about its concerns with ocular toxicity seen in trial data submitted by ...

Issues at San Francisco Research Institute

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FDA warns Dr. Mark Savant and his San Francisco Research Institute about bioresearch monitoring violations in his conduct of a cli...

Biocons Interchangeable Insulin Approved

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FDA approves a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product Kirsty (insulin aspart-xjhz).