Drug Approval | February 19, 2022
US FDA to review Amylyx new drug application for AMX0035
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
FDA changes inspection classification of the facility to Voluntary Action Indicated
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Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
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