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Pharma Now Editorial Team
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Pharma Now Editorial Team
Pharma Now Editorial Team
Pharma Now Editorial Team
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Selumetinib Label Expands to Age 1 via Granule Bridging Strategy
FDA approves selumetinib granules for NF1 patients from age 1, using bioavailability bridging rather than a new efficacy trial.
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ADMA Biologics Secures Fifth ASCENIV Approval Letter, FDA Extends Lot Expiry
FDA issues fifth ASCENIV approval letter for ADMA Biologics and extends expiry on six 2019-2020 lots, with compliance implications for biologics manufacturers.
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Mifepristone Access Restored via Telehealth, Mail, and Pharmacy
Supreme Court restores mifepristone access via telehealth, mail, and pharmacies, with REMS compliance obligations unchanged.
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First New Motion Sickness Drug in 40 Years Reaches U.S. Shelves
Vanda Pharmaceuticals launches NEREUS, the first new motion sickness treatment approved in over 40 years, now available at U.S. retail pharmacies.
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