Drug Approval | February 13, 2025
FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis
EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA
Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)
The inspection was carried out from January 28 to February 1, 2025
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
This certification will open new markets for the Kwality Pharma
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