Regulatory

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FDA Grants Accelerated Approval to Novartis’ Scemblix for Newly Diagnosed Chromosome-Positive Chronic Myeloid Leukemia
FDA Grants Accelerated Approval to Novartis’ Scemblix for Newly Diagnosed Chromosome-Positive Chronic Myeloid Leukemia

October 30th 2024

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix's superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

FDA Approves Protega Pharmaceuticals’ Roxybond for Severe Pain Management
FDA Approves Protega Pharmaceuticals’ Roxybond for Severe Pain Management

October 29th 2024

MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?

October 25th 2024

FDA Expands Indication of Alvotech and Teva’s Stelara Biosimilar
FDA Expands Indication of Alvotech and Teva’s Stelara Biosimilar

October 22nd 2024

FDA Approves Allergan Aesthetics’ Botox Cosmetic for Moderate to Severe Vertical Platysma Bands
FDA Approves Allergan Aesthetics’ Botox Cosmetic for Moderate to Severe Vertical Platysma Bands

October 21st 2024

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