Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 26

Results For "U.S.-FDA"

291 News Found

Glenmark receives ANDA approval for hydrochlorothiazide tablets
Drug Approval | January 27, 2022

Glenmark receives ANDA approval for hydrochlorothiazide tablets

According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million


Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
Drug Approval | January 17, 2022

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection

The company has 47 ANDA's pending approval with the U.S.FDA


Clarivate identifies seven potential blockbuster drugs in Annual Drugs to Watch report
News | January 10, 2022

Clarivate identifies seven potential blockbuster drugs in Annual Drugs to Watch report

Despite the challenges of pandemic disruptions, drug developers advance promising therapies for conditions, including Alzheimer's, diabetes and asthma


Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis
Biotech | December 24, 2021

Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis

Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine


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


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


Aadi Bioscience secures U.S FDA approval of its first product Fyarro
Drug Approval | November 26, 2021

Aadi Bioscience secures U.S FDA approval of its first product Fyarro

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults