Drug Approval | November 11, 2022
Sanofi, GSK’s next-generation COVID-19 booster vaccine approved by the European Commission
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
The acquisition of these two brands expands Lupin's portfolio of inhalation products in the U.S.
Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data
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