USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression
The company received 1 (One) observation in the Form-483
25 women students to receive internship, training, and mentorship in Life Sciences segment
Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume
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