US FDA declines to approve injection form of J&J's lung cancer drug

Quick Summary:

The currently approved intravenous formulation of Rybrevant was not impacted, the company added.

It is unrelated to the product formulation, or the efficacy and safety data submitted, the company said, adding that the FDA has not requested any additional clinical studies.

The FDA's so-called complete response letter was related to observations as part of a standard pre-approval inspection at a manufacturing facility, J&J said.

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Category: BusinessFinance

Markets: IndiaUnited States

Topics: Food and Drug Administration Lung cancer

Source Website Secure: Yes (HTTPS)

News Sentiment: Negative

Fact Checked: Legitimate

Article Type: News Report

Published On: 2024-12-17 @ 08:40:50 (7 hours ago)

News Timezone: GMT +5:00

News Source URL: business-standard.com

Language: English

Article Length: 334 words

Reading Time: 2 minutes read

Sentences: 13 lines

Sentence Length: 26 words per sentence (average)

Platforms: Desktop Web, Mobile Web, iOS App, Android App

Copyright Owner: © Business Standard

News ID: 24486237

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