Regulatory
The latest in regulatory for medical-aesthetics practice owners.
Regulatory Medicare to Negotiate Botox Price This Year — What Payers' Leverage Means for Your Margins
Botox joins 14 other drugs in CMS negotiation; injectable economics face fresh pressure.
Regulatory Galderma Provides Update on Relabotulinum BLA — Third Toxin Competitor Advances Toward FDA Approval
Regulatory progress on Galderma's botulinum toxin candidate keeps competitive pressure on Allergan and Revance.
Regulatory Galderma Updates Relabotulinum BLA Status With FDA — Third Neuromodulator Nears U.S. Approval
Regulatory progress on Galderma's botulinum toxin candidate; competitive pressure on pricing.
Regulatory Galderma Provides Update on RelabotulinumtoxinA BLA Review — Third Botulinum Toxin Competitor Advances
Galderma's neuromodulator candidate moves through FDA Biologics License Application review.
Regulatory Galderma's Relfydess Botox Rival Hits FDA Roadblock — What Practices Need to Know
The FDA issued a Complete Response Letter for RelabotulinumtoxinA, delaying Galderma's entry into the U.S. neuromodulator market.
Regulatory Galderma Gets Complete Response Letter on RelabotulinumtoxinA — What Went Wrong
FDA rejects Galderma's Botox rival on first submission; company faces clinical or manufacturing gaps.
Regulatory Galderma Receives Complete Response Letter for Relfydess — Botox Rival Faces Regulatory Hurdle
FDA rejects Galderma's new neuromodulator formulation; shares slide on failed market-entry bid.
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