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Results For "FDA"

1712 News Found

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


Alkem licenses technology from Harvard to treat ischemic injury and vascular diseases
Biotech | March 03, 2022

Alkem licenses technology from Harvard to treat ischemic injury and vascular diseases

Novel delivery of established growth and neurotrophic factors enables local, sustained release for greater efficacy


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


Avenge Bio announces peer-reviewed publication on preclinical proof of concept for LOCOcyte platform technology
Biotech | March 03, 2022

Avenge Bio announces peer-reviewed publication on preclinical proof of concept for LOCOcyte platform technology

Ovarian cancer is one of the most difficult cancers to treat. It is typically not detected until later stages, and about 70 percent of patients will have recurrence after an initial treatment, which is often fatal


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


Lupin launches Sevelamer Hydrochloride tablets in the United States
Drug Approval | March 01, 2022

Lupin launches Sevelamer Hydrochloride tablets in the United States

Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg


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


Prenetics Partners and ACON Bio launch Covid-19 antigen kits
Medical Device | February 27, 2022

Prenetics Partners and ACON Bio launch Covid-19 antigen kits

Flowflex antigen test detects Covid-19, including the Omicron variant, in just 15 minutes with 98.8% accuracy


DiscGenics presents positive Phase1/2 study of Cell therapy for degenerative disc disease
Biotech | February 27, 2022

DiscGenics presents positive Phase1/2 study of Cell therapy for degenerative disc disease

Allogeneic discogenic cell therapy was well tolerated and produced clinically meaningful, statistically significant improvements in low back pain, function, and quality of life by 12 weeks following intradiscal injection