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FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

[ Price : $8.95]

FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in com...

FDA Declines to Approve Sobi Gout Therapy

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FDA issues Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricas...

EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing

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The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedl...

OAI Inspections at U.S. Drug Sites Surpassed India in 2025: Analysis

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A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of...

Capricor's Duchenne Cell Therapy Set for Advisory Committee Review

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FDA informs Capricor Therapeutics that it has scheduled an advisory committee meeting to review the company's BLA resubmission for...

Dr. Reddy's Gets 7-Item FDA Form 483 After Biologics Inspection

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FDA cites Dr. Reddy's Laboratories in a seven-observation Form 483 following a recent pre-license inspection of its biologics manu...

Lantheus Gets Complete Response Letter for Tumor Imaging Agent

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FDA issues Lantheus a Complete Response Letter for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emi...

Report: Three Finalists Emerge in Next Commissioner Search

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Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar wit...

Antibody Impurity Guidance Needs Specificity: Comments

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Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.

Stakeholders Comment on AI-Enabled Trial Pilot

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Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.