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USFDA to lift import alert on Sun Pharma’s Mohali facility

Regulator will permit the supply of products from Mohali facility inherited by Sun Pharma from Ranbaxy, to the US market .........

USFDA accepts Mylan & Biocon’s proposed biosimilar Pegfilgrastim for review

The development marks the second successful biologics license application (BLA) for filing of the partnership in the United States of America...

Strides Shasun receives USFDA tentative approval for Fingolimod capsules

On receiving full approval, the product will be manufactured at the company’s oral dosage facility at Bangalore and marketed by its subsidiary in USA, Strides Pharma Inc....

Laser-assisted cataract treatment to benefit 74% of 60 year old Indians

US Food and Drug Administration (US-FDA) approved LenSx Laser system is the market leader in the Femto-laser segment which has performed more cataract surgeries worldwide than any other laser system....

US-FDA accepts Mylan & Biocon’s joint application on biosimilar Trastuzumab

While the Biologics License Application (BLA) for MYL-1401O has been accepted by the United States FDA, if approved, it has the potential to be the first biosimilar Trastuzumab in the US....

Bharat Biotech’s Zikavac to enter phase-I clinical trials

The company's Zika vaccine has completed pre-clinical studies and is now awaiting the regulator's approval to begin phase-1 trials.....

Strides Shasun receives USFDA tentative approval for Efavirenz

Product approval has been granted for the oral dosage produced at the company facility based out of Bangalore...

FDA Advisory Committee recommends approval of Sanofi’s Type 2 Diabetes cure

FDA decisions on the investigational fixed-ratio combination of basal insulin glargine is expected in third quarter of 2016...