Drug Approval | August 28, 2021
DCGI approves Enzene biosimilar Denosumab for Osteoporosis
This is Enzene Biosciences third biosimilar to be approved
This is Enzene Biosciences third biosimilar to be approved
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider
The clinical research organisation located in Hyderabad is a USFDA inspected facility
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease
The acquisition was expected to be completed in eight weeks, and it would have provided it with a foothold in the US $ 48 billion global animal health market
FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.
Price erosion, weak demand for acute portfolio and low ANDA approvals in the US weighed on the performance of Indian pharma in Q1FY22. However, the scenario is expected to change in H2FY22 when new approvals and inspections resume
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