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Complete Response on BLA for Lung Cancer Combo

[ Price : $8.95]

FDA sends Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating certa...

Schakowsky Introduces Drug Import Bill

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Rep. Jan Schakowsky and seven others introduce legislation to authorize the importation of prescription drugs from Canada, the UK,...

START Pilot Helps Rare Disease Treatments: Cavazzoni

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CDER and CBER announce seven participants in the START pilot program to speed development of treatments for rare diseases.

Torrent Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with five observations from an inspection at the Torrent Pharmaceuticals facility in Indrad, Gujarat...

FDA De Novo Authorization for Hep C Test

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FDA grants a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System for detecting hepatitis...

PZAD Designation, Review Process Guidance

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FDA publishes a guidance to help sponsors pursue Priority Zoonotic Animal Drug designation for a new animal drug.

Guidance on Study Underrepresentation Diversity Plans

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FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enr...

Verona Gets Ohtuvayre Approval for COPD

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FDA approves a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disea...

BrainStorm Gets FDA Alignment on CMC Issues

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BrainStorm Cell Therapeutics says it has reached alignment with FDA on chemistry, manufacturing, and controls aspects of the compa...

CDRH Joins Gates Foundation on Analytic Methods

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CDRH says it is partnering with the Bill and Melinda Gates Foundation and the National Institute for Standards and Technology on a...