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Results For "USFDA"

1127 News Found

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


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches


Industry seeks favourable policy for India to move up the pharma value chain globally
Policy | February 27, 2022

Industry seeks favourable policy for India to move up the pharma value chain globally

N Yuvraj, Joint Secretary, Dept of Pharmaceuticals, Satish Reddy, Chairman, Dr Reddy’s Laboratories; Kiran Mazumdar Shaw, Executive Chairperson, Biocon Group; Sanjiv Navangul, MD & CEO, Bharat Serums and Vaccines and Shravil Patel, MD, Zydus Lifesciences discuss the way forward for the India pharma industry


Risk appetite key to innovation in pharma and biopharma
News | February 25, 2022

Risk appetite key to innovation in pharma and biopharma

Industry leaders discusses the need of innovation for the Indian drug industry at BioAsia 2022.


Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction
Drug Approval | February 25, 2022

Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction


Aadi Bioscience launches Fyarro in the USA
Biotech | February 24, 2022

Aadi Bioscience launches Fyarro in the USA

Fyarro added to NCCN guidelines as the only preferred mTOR inhibitor to treat malignant PEComa