Drug Approval | November 04, 2023
Lupin receives tentative approval from USFDA for Selexipag for injection
This product will be manufactured at Lupin's Nagpur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023
Revenue in the three months ended on Oct. 1 also slipped by 42% to US$ 13.23 billion
India is following a holistic and inclusive approach in alignment with the vison of Universal Health Coverage and the resolute commitment to ‘leave no one behind
The companies plan to start a pivotal Phase 3 trial in the coming months
RHTC will address a long-standing healthcare access issue for all the local population
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
The company expects that this development could improve the strength of its application to the FDA for new drug approval
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