Drug Approval | September 04, 2025
Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations
The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season
Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
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