Gland Pharma receives USFDA approval for Eribulin Mesylate Injection
The Product is expected to be the first generic approval on the market
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
The approval marks a significant milestone for the American pharmaceutical company in the field of UC
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
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
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