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Interchangeability Status on Celltrion Biosimilars

[ Price : $8.95]

FDA grants interchangeability designations to Celltrions denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-...

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...

FDA to Unveil Faster Pathway for Gene-Editing Therapies

[ Price : $8.95]

CBER director Vinay Prasad says FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapi...

FDA Moves to Restrict Unapproved Fluoride Drugs

[ Price : $8.95]

FDA announces new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs.

Improving Cancer Trial Comparators: White Paper

[ Price : $8.95]

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

[ Price : $8.95]

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...

FDA Clears Tosohs Next-Generation HbA1c Analyzer

[ Price : $8.95]

FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) test...