Drug Approval | December 20, 2022
USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
None of the observations are related to data integrity and management believes that they are addressable
None of the observations are related to data integrity and management believes that they are addressable
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
The company will submit an action plan on the observations and will engage with US FDA for next steps.
This was a pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
Patients receiving Polivy plus R-CHP for DLBCL reported similar health-related quality of life outcomes
Soluplus branded excipient play a critical role in enabling the drug development process for poorly soluble active pharmaceutical ingredients
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
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