Drug Approval | December 05, 2022
Zydus receives final approval from USFDA for Estradiol Transdermal System
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Evaluating Investigational Sitravatinib in combination with Nivolumab for patients with non-squamous non-small cell lung cancer
Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
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