Drug Approval | October 14, 2024
Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Indoco is comprehensively working on the remedial action plan
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
The observations are of procedural in nature and will be responded to within the stipulated time
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