The trial targets MCAS/MCAD, an under-recognized, debilitating condition with an unknown cause and no cure
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
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio
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
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Adjusted EBITDA positive at Rs. 3.1 crore despite investments in marketing, talent hiring and technology over the year
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