Dr Reddy’s announces launch of Colchicine Tablets USP in the US
It is available in 0.6 mg tablets in bottle count sizes of 30s and 100s
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US Food and Drug Administration
US FDA approves first drug to image Tau Pathology in Alzheimer’s Disease related cases
Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s…
AstraZeneca-Merck’s Lynparza gets US FDA nod for prostate cancer treatment
The drug approval by the US regulator is for treating patients with a form of prostate cancer that could not be held back by…
Gilead signs Voluntary Licensing Agreements with Cipla, Hetero Labs, Jubilant Lifesciences, Mylan…
Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process…
US emergency approval broadens use of Gilead’s COVID-19 drug remdesivir
Gilead said that the drug, which is given by intravenous infusion, had helped improve outcomes for patients with COVID-19, the…
US FDA accepts Mylan and Biocon’s proposed biosimilar bevacizumab for review
The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is December 27, 2020 Biocon and Mylan announced that the US…
FDA launches interactive, PDF-based template to promote greater efficiency and consistency in…
The FDA will select up to nine participants who provide a holistic representation of the medical device industry and meet the…
US FDA cautions Aurobindo Pharma’s oral solids formulation facility of regulatory action
According to US FDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA…
FDA launches mobile-friendly database with information on life-saving HIV drugs
The interactive tool offers information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief…
FDA approves first treatment for inherited rare disease
The approval of the drug, Givlaari was based on the results of a clinical trial of 94 patients with acute hepatic porphyria