FDA

FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer’s Disease in the US

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FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer’s Disease in the US

creativebharatgroup@gmail.com January 27, 2025

Stockholm, January 27, 2025 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today...

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FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.

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FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.

creativebharatgroup@gmail.com January 17, 2025

Richmond, Va., United States:   FDA decision makes ZYN the first authorized nicotine...

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FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US

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FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US

creativebharatgroup@gmail.com January 14, 2025

Stockholm, January 14, 2025 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today...

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Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting

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Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting

creativebharatgroup@gmail.com January 10, 2025

Diamyd Medical provides an update following the receipt of final meeting minutes from...

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Lundbeck announces FDA plans to host an Advisory Committee meeting on the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD

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Lundbeck announces FDA plans to host an Advisory Committee meeting on the sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD

creativebharatgroup@gmail.com January 9, 2025

H. Lundbeck A/S (Lundbeck) announces that the U.S. Food and Drug Administration...

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Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis

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Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis

creativebharatgroup@gmail.com December 14, 2024

Zug, Switzerland:   Ad hoc announcement pursuant to Art. 53 LR   ...

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SyntheticMR receives FDA 510(k) clearance for SyMRI 15

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SyntheticMR receives FDA 510(k) clearance for SyMRI 15

creativebharatgroup@gmail.com December 6, 2024

SyntheticMR, leader in quantitative imaging software, is pleased to announce that its SyMRI...

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U.S. FDA Approves AOP Health’s Rapiblyk™ (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

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U.S. FDA Approves AOP Health’s Rapiblyk™ (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

creativebharatgroup@gmail.com November 27, 2024

Vienna, Austria:   AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria,...

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