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Results For "USFDA"

1205 News Found

IDMA set for its Diamond Jubilee celebrations on April 14-15th
News | April 13, 2022

IDMA set for its Diamond Jubilee celebrations on April 14-15th

The association has lined up a string of prominent speakers from the government and private sector. Seasoned veterans and industry bigwigs will grace the two-day event in Mumbai


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


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


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


Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore
News | April 05, 2022

Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore

Casper Pharma is a Hyderabad based SEZ company engaged in the formulations business. Post-purchase of shares, the target entity would become a wholly-owned subsidiary of SPL


CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds
Biotech | March 31, 2022

CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds

Air purification system achieves Intertek zero ozone certification


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies


Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes
Drug Approval | March 29, 2022

Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults


Novavax to participate in two booster studies using its COVID-19 vaccine
Biotech | March 26, 2022

Novavax to participate in two booster studies using its COVID-19 vaccine

U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current USFDA approved or emergency use authorized-vaccines


Merck’s Keytruda approved for fourth gynecologic cancer indication
Drug Approval | March 22, 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial