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Results For "ANDA"

2091 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


Venus Remedies gets CII's Responsible Export Organisation Certification
News | April 13, 2022

Venus Remedies gets CII's Responsible Export Organisation Certification

A comprehensive assessment of the organisational systems for governance, management, operations and consistency in delivered results, this certification is an endorsement of the company's export capabilities and manufacturing prowess


Wacker, CordenPharma to produce mRNA vaccines for Germany
News | April 12, 2022

Wacker, CordenPharma to produce mRNA vaccines for Germany

Both companies have been selected for stand-by production by German government


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


Telix Pharmaceuticals announces licence agreement with Lilly for olaratumab
Biotech | April 11, 2022

Telix Pharmaceuticals announces licence agreement with Lilly for olaratumab

Lilly may be eligible for up to US $ 225m in payments based upon the achievement of pre-specified development, regulatory and commercial milestones


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


Global pharma back Turn Biotechnologies to advance its cell rejuvenation program
Startup | April 11, 2022

Global pharma back Turn Biotechnologies to advance its cell rejuvenation program

Daewoong Pharmaceutical, HanAll Biopharma join Astellas Venture Management and other VCs in oversubscribed funding round to accelerate Turn Bio's preclinical advances in multiple therapeutic areas


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


Ministry of Ayush to organise two-day convention on World Homeopathy day
News | April 09, 2022

Ministry of Ayush to organise two-day convention on World Homeopathy day

World Homoeopathy Day is observed to commemorate the birth anniversary of the founder of Homoeopathy, Dr. Christian Fredrich Samuel Hahnemann to mark his 267th birth anniversary