Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Shots: The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1…

ByDipanshu DixitFebruary 23, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2023

Shots:The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Insights+: The US FDA New Drug Approvals in April 2023

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