Drug Approval | November 23, 2022
USFDA grants priority review of BLA for dengue vaccine TAK-003
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
The observation is procedural in nature and the company will address the observation within stipulated timelines.
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
The inspection concluded with no observation (FDA-483) issued.
Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.
This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
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