Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Idorsia Requests DEA Lift Controlled Substance Restrictions On Dual Orexin Receptor Antagonists For Insomnia
Schedule IV classification for Idorsia’s Quviviq, along with Merck & Co’s Belsomra and Eisai’s Dayvigo, distorts the drug class’ benefit-risk profile relative to other insomnia treatments, which are prioritized for prescribing but carry higher risk of abuse and other adverse events, company says.
Mitsubishi’s Oral Radicava Provides Convenience Option For ALS
Oral or feeding tube administration of the cerebral neuroprotectant should offer flexible dosing options for amyotrophic lateral sclerosis patients, the firm says.
US Biosimilar Outlook: Inspections, Interchangeability And Positioning For The Post-Humira Era
Six of the 10 biosimilar candidates under FDA review are waiting on inspections delayed by COVID-19; in the meantime, sponsors jockey for position when Humira biosimilar launch windows open up next year.