Results For "U.S.FDA"

18 News Found

U.S. FDA approves ANI’s purified cortrophin gel

Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016

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

Latest Stories

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

FUJIFILM India unveils four new imaging & healthcare IT solutions at IRIA 2026

White Papers

Chasing Consistency: Centralizing operations data is the key to optimizing chemicals plants

Implementing a digital transformation in chemical operations to maximize profitability

The complexity of compliance

The Sprint to the Summit: Unlocking Lab Efficiency through Digital Transformation

The guiding role of fluidized and spouted bed technologies in particle building processes

Interviews

Only 4-5 Indian pharma companies have a strong presence in Russia, opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group

Only 4-5 Indian pharma companies have a strong presence in Russia, opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group

Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group

Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group

Companies must shift from L1 costing to Life Cycle Cost Analysis: Abhilash Pasham, Associate GM - Central Engineering & Projects, Dr. Reddy's Laboratories

Companies must shift from L1 costing to Life Cycle Cost Analysis: Abhilash Pasham, Associate GM - Central Engineering & Projects, Dr. Reddy's Laboratories

Packaging