Drug Approval | July 22, 2024
Briefs: Zydus Lifesciences and Divi's Laboratories
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date
Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD
Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA
With this, for all our USFDA facilities, EIRs are in place
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
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This facility manufactures APIs & formulations of oncology and non-oncology products.
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
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