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
Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The company had responded to the agency and carried out the required corrective actions.
This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
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