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FDA Posts 2 Biosimilar Development Guides

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FDA releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on cl...

Firm Pays $40 Million Over Adulterated Gowns

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Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adultera...

Gottlieb Warns HHS Could Undermine Pediatric Vaccines

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Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report ...

FDA Guidance on Good Clinical Practice Principles

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FDA issues an updated guidance entitled E6(R3) Good Clinical Practice (GCP) that describes GCP principles, emphasizing flexible, m...

Lillys Jaypirca Shows Major Benefit in Leukemia Trial

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New trial data show Eli Lillys Jaypirca (pirtobrutinib) significantly extended progression-free survival in previously untreated p...

Merck Reports Favorable Lung Cancer Drug Data

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Merck reports favorable results from the IDeate-Lung01 Phase 2 trial showing that ifinatamab deruxtecan demonstrated clinically me...

Complete Response on Saol Therapeutics NDA

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FDA issues Saol Therapeutics a complete response letter on its NDA for SL1009 (sodium dichloroacetate oral solution) for treating ...

Positive Data on New Breast Cancer Drug

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BioNTech and Duality Biologics report that trastuzumab pamirtecan met its primary endpoint in a pivotal Phase 3 trial for patients...

Green List to Block Illegal GLP-1 Imports: FDA

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FDA unveils a new green list import alert aimed at preventing unapproved and potentially unsafe GLP-1 drug ingredients from enteri...

CERo Gets Fast Track for Leukemia Therapy

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FDA grants CERo Therapeutics fast track status for CER-1236 and its use for treating acute myeloid leukemia.