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Safety Data Update on Hintermann Ankle Device

[ Price : $8.95]

FDA issues an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ank...

Lilly Hopeful Obesity Pill Accepted in Voucher Program

[ Price : $8.95]

Eli Lilly says its investigational weight-loss pill met most criteria for FDAs new national priority voucher program and could be ...

J&J Seeks Stelara Expanded Use

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA seeking to expand the use of its biologic therapy Stelara (ustekinumab) to treat childr...

Senators Want Foreign Generic Drug Info

[ Price : $8.95]

Leaders of the Senate Special Committee on Aging ask executives of three group purchasing organizations a series of questions abou...

Hire Staff, Improve Morale, Cut INDs: Tidmarsh Goals

[ Price : $8.95]

New CDER director George Tidmarsh talks about hiring new reviewers, improving staff morale, and finding ways to safely speed drug ...

FDA Fast Track for Alphamab Cancer Drug

[ Price : $8.95]

FDA grants fast-track designation to Alphamab Oncologys JSKN003 to treat several cancers.

Court Finds Mifepristone REMS Unlawful

[ Price : $8.95]

A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.

Improving Cancer Trial Comparators: White Paper

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A Friends of Cancer Research working group suggests ways to overcome challenges in selecting standard of care comparators for onco...

Zydus Lifesciences FDA-483 Out

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FDA releases the form FDA-483 with four observations from an inspection at the Zydus drug manufacturing facility in Baddi, India.

Clinical Hold on 2 Intellia Gene Therapy Trials

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FDA issues a clinical hold on Intellia Therapeutics MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran after the co...