SPARC submitted a new drug application (NDA) to the US Food and Drug Administration (US FDA) for this product for the treatment of seizures in newborns in February 2022, according to Sun Pharma statement shared with stock exchanges.
Mumbai (Maharashtra) [India], May 28 (ANI): Glenmark Pharmaceuticals Limited on Saturday reported a net consolidated profit of Rs 172.6 crore for the quarter ended March 2022 as compared to Rs 234 crore recorded in the corresponding period of the last year, registering a decline of 26 per cent.
Washington [US], May 6 (ANI): The US Food and Drug Administration (FDA) on Thursday said that the Johnson & Johnson vaccine that has been administered to more than 18 million Americans can potentially cause "life-threatening blood clots", and thereby warranted "limiting the authorized use of the vaccine."
A COVID-19 diagnostic test has come to light that uses breath samples to generate a positive or negative result. It has received emergency use authorization from the US Food and Drug Administration (FDA). Dubbed ‘InspectIR’, this breath analyzer COVID-19 test detects chemical components linked to coronavirus in breath samples. “Today’s authorization is yet another example […]
Watertown (Massachusetts) [US], February 15 (ANI/BusinessWire India): Since the start of the pandemic, non-contact infrared thermometers (NCITs) have been widely used as a screening method for fever detection in healthcare and public settings, as fever is a leading sign of COVID-19. Now, a new FDA published study demonstrates their failure to reliably detect fevers when used on adults in accordance with the NCIT instructions and fail to be within the accuracy specifications as advertised in manufacturers' literature, instructions for use, and other labeling.
Mumbai (Maharashtra) [India], February 15 (ANI/PR Newswire): Datar Cancer Genetics today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Designation' for its blood test to detect early-stage prostate cancer. This is the second test from the Company that has received the Breakthrough Device Designation from the US FDA. Late last year, the company's breast cancer detection test became the first such test to receive the designation.
Mumbai (Maharashtra) [India], November 20 (ANI/PRNewswire): Datar Cancer Genetics, a leading cancer research company today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Designation' for its blood test to detect early-stage Breast Cancer.
Geneva [Switzerland], September 23 (ANI/PRNewswire): MedAlliance, with its Japanese partner MDK Medical, has completed enrollment in the clinical study of its novel Sirolimus Drug Eluting Balloon (DEB), SELUTION SLR™, for the treatment of peripheral arterial disease (PAD).
New York [US], August 17 (ANI): Pfizer and BioNTech announced that they have submitted Phase 1 data to the United States Food and Drug Administration (FDA) to support the evaluation of a third, or booster dose of the companies' COVID-19 vaccine for future licensure.
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