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Lilly Filing NDA for Expanded Tirzepatide Use

[ Price : $8.95]

Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently mar...

Restrictions on Lutathera ANDA Sought

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Novartis asks FDA to impose limits on applications for generic forms of its Lutathera radioligand.

Sun Pharma Hit With 483 After India Inspection

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FDA issues Sun Pharmaceutical Industries a six-item Form-483 following a two-week December inspection at the firms Dadra, Dadra & ...

Soulaire Marketing Unapproved Device: FDA

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FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbrandin...

2 CGMP Violations in Natco Pharma Inspection

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FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs...

Clinical Trial Innovation Center Established

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CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to...

Ex-CEO Sentenced Over Phony Covid Test

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A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for a securities fraud scheme invo...

FDA Warns on Suspected Counterfeit Botox

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FDA issues a safety alert on unsafe counterfeit versions of AbbVies Botox (botulinum toxin) have been found in multiple states and...

Xstim Spine Fusion Stimulator Approved

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FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.

CBER Joining Lupus Research Consortium

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FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focus on engineered cell therapies...