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1679 News Found

USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS
Biotech | April 13, 2022

USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS

An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)


Zydus to supply Sagent's caffeine citrate oral solution from Jarod
Biotech | April 13, 2022

Zydus to supply Sagent's caffeine citrate oral solution from Jarod

This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants


Aleor receives USFDA approval for Lidocaine and Prilocaine Cream
Drug Approval | April 12, 2022

Aleor receives USFDA approval for Lidocaine and Prilocaine Cream

Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA


CUHK researchers discover distinct gut microbial signatures for prediction, diagnosis and treatment of long Covid
Biotech | April 11, 2022

CUHK researchers discover distinct gut microbial signatures for prediction, diagnosis and treatment of long Covid

These distinct gut microbial signatures can be used to predict the risk of developing long Covid and diagnose long Covid in patients with persistent symptoms after the acute infection


Amyris commissions industry-leading fermentation plant
Biotech | April 11, 2022

Amyris commissions industry-leading fermentation plant

The site consists of five fermentation "mini-factories" capable of concurrently producing our more than 13 currently scaled and future bio-fermented products


LivaNova initiates targeted commercial launch of Essenz patient monitor
Biotech | April 10, 2022

LivaNova initiates targeted commercial launch of Essenz patient monitor

An intuitive monitor featuring a patient-tailored approach is now in clinical use in select centres in U.S. and Europe


Knowledge Centre for Pharmaceutical Continuous Manufacturing
Biotech | April 08, 2022

Knowledge Centre for Pharmaceutical Continuous Manufacturing

Although PCM has advanced substantially in recent years, most of the valuable technical information resides with private companies and academic publications across multiple platforms


Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test
Biotech | April 08, 2022

Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test

If authorized by the USFDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for Covid-19 in as little as 18 minutes


JB Chemicals and Pharmaceuticals partners with Akshay Chaitanya to provide free lunch in hospitals
Sustainability | April 07, 2022

JB Chemicals and Pharmaceuticals partners with Akshay Chaitanya to provide free lunch in hospitals

Under this initiative, 700 meals will be provided every day to four hospitals in Mumbai