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Results For "USFDA"

1130 News Found

Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance
People | April 27, 2022

Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance

Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)


‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology
Biotech | April 25, 2022

‘DREAM-ND’ and ‘DREAM-D’ Phase 3 trials of Desidustat published in American Journal of Nephrology

Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia


Dr. Reddy's launch Posaconazole delayed-release tablets in the US
Drug Approval | April 21, 2022

Dr. Reddy's launch Posaconazole delayed-release tablets in the US

The tablets are available in 100 mg strength in bottle count sizes of 60


Amneal achieves second U.S. biosimilars approval with Alymsys
Drug Approval | April 18, 2022

Amneal achieves second U.S. biosimilars approval with Alymsys

Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022


Evexia Lifecare's Vadodara API facility starts operations
News | April 17, 2022

Evexia Lifecare's Vadodara API facility starts operations

The company also plans to expand the facility


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