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Imbed Bio Lidocaine Wound Dressing Cleared

[ Price : $8.95]

FDA clears an Imbed Biosciences 510(k) for its Microlyte Ag/Lidocaine, an antimicrobial wound dressing that integrates lidocaine f...

Use Risk-Based AI/ML Regulation: AstraZeneca

[ Price : $8.95]

AstraZeneca provides four comments to the FDA docket on considerations for generative artificial intelligence/machine learning ove...

Datex-Ohmeda Recalls Giraffe OmniBeds

[ Price : $8.95]

GE HealthCare subsidiary Datex-Ohmeda recalls its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions...

UCBs Bepranemab Misses Primary Endpoint

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UCB says its investigational Alzheimers drug bepranemab missed the primary endpoint in a Phase 2a trial but hit secondary endpoint...

Verastem Oncology NDA for Rare Ovarian Cancer

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Verastem Oncology completes a rolling NDA submission for the combination of avutometinib and defactinib for adults with recurrent ...

Court Backs FDA Lumryz Approval

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The DC federal court tosses a Jazz Pharmaceuticals suit against FDA over the agencys approval of Avadels narcolepsy drug Lumryz be...

Guides on Bioequivalence Study Designs

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Federal Register notice: FDA makes available a final guidance entitled M13A Bioequivalence for Immediate-Release Solid Oral Dosage...

Organon/Shanghai Henlius Seek Biosimilar Approval

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FDA accepts for review a Shanghai Henlius Biotech and Organon BLA for their biosimilar of Amgens Prolia/Xgeva (denosumab).

ICH Bioquivalence Guidance Out

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FDA publishes the International Council for Harmonization M13A guidance on bioequivalence studies for immediate-release solid oral...

Sage/Biogen Nix Expanded Use for Zurzuvae

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Sage Therapeutics and Biogen decide to not seek an expanded use (major depressive disorder) for postpartum depression drug Zurzuva...