ALK-Abelló A/S announced that the Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) has voted that the available data support the efficacy and safety of Merck's RAGWITEK(tm). RAGWITEK(tm) is the proposed US trade name of the ragweed sublingual allergy immunotherapy tablet, licensed to Merck for North America by ALK. The FDA is currently reviewing Merck's Biologic License Application (BLA) for RAGWITEK(tm) for the treatment of ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age.
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Jun. 21 | ALK-Abelló A/S Updates Revenue Guidance for the Year 2024 | CI |
Jun. 21 | ALK Provides Update on Regulatory Process for the House dust Mite Allergy Tablet in China | CI |
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- FDA Advisory Committee Recommends Approval of Ragweed Sublingual Allergy Immunotherapy Tablet of ALK-Abelló A/S