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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 ...

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...

Spanberger Wants More ADHD Drug Info

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Rep. Abigail Spanberger asks FDA and DEA for additional information on their efforts to address shortages of ADHD drugs.

Boehringer Ingelheim Inspection Report Posted

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FDA posts the establishment inspection report with seven observations from a 2023 inspection at a Boehringer Ingelheim drug manufa...

FDA Removes Imaging Ban on FreeStyle Libre

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FDA approves the removal of an imaging contraindication on Abbotts FreeStyle Libre 2 and 3 continuous glucose monitoring systems.

More ANDA Product-Specific Guidances

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Federal Register notice: FDA makes available additional revised draft product-specific guidances that provide recommendations on b...

Advisors Asked About Lexicons Sotagliflozin

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FDA raises questions to be considered at a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting discussing a Lexico...