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Browsing Tag
USFDA
Concept Medical receives 2nd IDE approval for its SCB MagicTouch PTA
The IDE approval will allow Concept Medical to gather safety and effectiveness data for the MagicTouch PTA SCB to support a future…
Indian-American researchers develop durable coating that kills COVID virus
The coating, which is clear and can be brushed or sprayed on, gets its durability and germ-killing power by combining…
US FDA approves first COVID-19 treatment for young children
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age
USFDA grants Breakthrough Designation to Datar Cancer Genetics for its prostate cancer detection…
It is the first blood test able to detect early-stage Prostate Cancer with high accuracy in men aged 55 years and above
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USFDA authorises first tests that estimate patient’s antibodies from past SARS-CoV-2 infection
Cautions patients against using the results from any serology test to stop social distancing, discontinuing wearing masks or…
US FDA sets new template for non-lab COVID-19 diagnostic test developers
New recommendations aim to help get tests to market that are simple enough to use at home, similar to a pregnancy test
COVID-19: Import licenses for rapid diagnostic kits of three firms cancelled, 16 suspended by DCGI
The three firms are Cadila Healthcare, MDAAC International and N W Overseas, while the 16 companies include Transasia…
Phase 3 COVID 19 clinical trials to be designed with stringent success criteria: International…
The meeting participants stressed the need for large phase 3 clinical trials that enroll many thousands of people, including those…
US FDA approves GSK’s HIV drug for patients with limited options
The oral treatment from the company’s HIV unit, ViiV Healthcare, has been approved for adults whose HIV infection could…