Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 2

Results For "U.S.FDA"

17 News Found

Biocon reports a consolidated net profit of Rs. 138.3 crore in Q2FY22
News | October 25, 2021

Biocon reports a consolidated net profit of Rs. 138.3 crore in Q2FY22

The Research Services and Biosimilars business segments reported a growth of 17% and 10%, respectively


Syngene reports better than expected revenues, margin pressure in Q1FY22: ICICI Direct
News | October 25, 2021

Syngene reports better than expected revenues, margin pressure in Q1FY22: ICICI Direct

Key takeaways of recent quarter & conference call highlights


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


FDA approves Cyltezo, the first interchangeable biosimilar to Humira
Drug Approval | October 20, 2021

FDA approves Cyltezo, the first interchangeable biosimilar to Humira

Second interchangeable biosimilar product approved by agency


U.S. FDA advisory committee recommends J&J booster dose
Biotech | October 18, 2021

U.S. FDA advisory committee recommends J&J booster dose

U.S. FDA to decide whether to authorize a booster dose in the coming days


Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA
Biotech | October 01, 2021

Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA

The company plans to submit the IND application by the end of 2021


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans