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CGMP API Deviations at Hikal Limited

[ Price : $8.95]

FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredient...

Issues in 3 Trials Conducted by Detroit Doctor

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FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three cli...

Former CBER Therapeutics Deputy Anatol Joins Lilly

[ Price : $8.95]

Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency p...

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 ...