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Results For "USFDA"

1162 News Found

Unichem receives ANDA approval for hypertension drug
Drug Approval | March 16, 2022

Unichem receives ANDA approval for hypertension drug

Nebivolol is used alone or together with other medicines to treat high blood pressure


UFDA approves first generic of Symbicort to treat asthma and COPD
Drug Approval | March 16, 2022

UFDA approves first generic of Symbicort to treat asthma and COPD

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing)


I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets


Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting
interviews | March 13, 2022

Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting

Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements


S.M.A.R.T. Radianz Vascular Stent System approved for transradial use in the U.S.
Medical Device | March 13, 2022

S.M.A.R.T. Radianz Vascular Stent System approved for transradial use in the U.S.

It signals Cordis' renewed investment in innovation


Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry
Biotech | March 09, 2022

Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry

Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder


WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


Limited impact of short-term disruptions, growth momentum to continue in FY 23
News | March 03, 2022

Limited impact of short-term disruptions, growth momentum to continue in FY 23

Large players are adequately capitalised to make bigger investments to adjust for the ongoing fundamental shift in market opportunities


SeQuent Scientific completes acquisition of Nourrie in Brazil
News | March 02, 2022

SeQuent Scientific completes acquisition of Nourrie in Brazil

Brazil has the 4th largest pet market in the world with an estimated market size of BRL 1.8 billion, growing annually at 16%


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022