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Results For "USFDA"

1126 News Found

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


U.S. FDA approves first and only injectable option for HIV prevention
Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


Sun gets US FDA approval for generic amphotericin B injection
Drug Approval | December 16, 2021

Sun gets US FDA approval for generic amphotericin B injection

It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity


U.S. FDA approves Bristol Myers Squibb’s Orencia
Drug Approval | December 16, 2021

U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune


Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug
Drug Approval | December 11, 2021

Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug

The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.


SPARC to present clinical data on vodobatinib
Biotech | December 11, 2021

SPARC to present clinical data on vodobatinib

Results from the ongoing vodobatinib clinical study are being presented for the second consecutive year at the ASH annual meeting, underlining the promising potential of the drug for the treatment of heavily pre-treated CML