Shivalik Rasayan’s API facility gets 7 observations from USFDA
These observations are procedural in nature and will be responded within the stipulated time
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
The Product is expected to be the first generic approval on the market
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery
The average time of dilation lasts three to eight hours
Application based on results from the TROPION-Breast01 Phase III trial
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