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Results For "FDA"

2075 News Found

Gland Pharma receives tentative approval for Cangrelor
Drug Approval | December 09, 2021

Gland Pharma receives tentative approval for Cangrelor

Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity


Dr Reddy’s launch valsartan tablets in the US market
Drug Approval | December 09, 2021

Dr Reddy’s launch valsartan tablets in the US market

Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90


Healthium Medtech opens manufacturing facility in Gujarat
News | December 09, 2021

Healthium Medtech opens manufacturing facility in Gujarat

The Uteshiya facility, licensed by Healthium, will exclusively manufacture Healthium’s arthroscopy portfolio, including patented products in India and U.S.


Lilly's bamlanivimab with etesevimab authorized for emergency use in Covid-19 patients under 12
Drug Approval | December 06, 2021

Lilly's bamlanivimab with etesevimab authorized for emergency use in Covid-19 patients under 12

Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients


Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark
Medical Device | December 06, 2021

Roche to launch SARS-CoV-2 and flu A/B Rapid Antigen Test in countries accepting the CE mark

The combination rapid antigen test quickly differentiates between SARS-CoV-2 and influenza viruses A and B infections, with results ready in less than 30 minutes, allowing informed decisions on patient and pandemic management decisions


Lupin and Biomm  tie-up for pegfilgrastim in Brazil
News | December 05, 2021

Lupin and Biomm tie-up for pegfilgrastim in Brazil

Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar


Unichem Labs gets ANDA approval for schizophrenia medicine
Drug Approval | December 03, 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant


Biocon Pharma receives ANDA approval for Mycophenolic acid
Drug Approval | December 03, 2021

Biocon Pharma receives ANDA approval for Mycophenolic acid

This further adds to Biocon’s portfolio of vertically integrated complex drug products


North America accounts for 50 % of generic pharma market
News | December 03, 2021

North America accounts for 50 % of generic pharma market

Going forward, the fastest-growing regions in the generic pharmaceuticals market will be South America and the Middle East, where growth will be at CAGRs of 10.1% and 9.4% respectively


Molnupiravir, a step closer to approval in the fight against Covid-19
News | December 02, 2021

Molnupiravir, a step closer to approval in the fight against Covid-19

The U.S. FDA advisory committee voted 13-10 in favour of the oral antiviral medicine