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Lunit Gets FDA Nod for AI-based Chest X-ray Triage Solution, Developed for Sorting of Emergency Cases prnasia
November 16, 2021
Lunit, a leading medical AI provider, today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest x-ray triaging solution, 'Lunit INSIGHT CXR Triage'.
FDA Approves Treatment for Rare Blood Disease FDA
November 16, 2021
Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.
FDA grants priority review to Boehringer-Lilly’s Jardiance for heart failure Pharmaceutical-Technology
November 15, 2021
Boehringer Ingelheim Pharmaceuticals and Eli Lilly have obtained the US Food and Drug Administration (FDA) priority review for Jardiance (empagliflozin) to potentially treat heart failure...
Pfizer Asks FDA to Approve Booster Shots for All U.S. Adults Drugs
November 11, 2021
As concerns mount that holiday travel and indoor gatherings will foster the spread of COVID-19, Pfizer on Tuesday asked the U.S. Food and Drug Administration to approve booster shots...
INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. prnewswire
November 10, 2021
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer...
Electronic Drug Registration and Listing Instructions FDA
November 10, 2021
There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates...
FDA declines to grant EUA for NRx’s Zyesami to treat Covid-19 patients Pharmaceutical-Technology
November 08, 2021
The US Food and Drug Administration (FDA) has declined to grant an emergency use authorization (EUA) for NRx Pharmaceuticals’ therapy, Zyesami (aviptadil), to treat critical Covid-19 patients who have respiratory failure.
US authorises more batches of J&J COVID-19 vaccine made at Emergent ExpressPharma
November 08, 2021
The US Food and Drug Administration (FDA) said it had authorised the use of two more batches of Johnson & Johnson’s one-dose COVID-19 vaccine manufactured at the problem-plagued Baltimore...
FDA provides EUA for Pfizer-BioNTech’s Covid-19 vaccine in children Pharmaceutical-Business-Review
November 05, 2021
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine for children aged 5 to 11 years.
FDA authorises Comirnaty® for emergency use in five to 11 year olds EuropeanPharmaceuticalReview
November 02, 2021
The US Food and Drug Administration (FDA) authorised the emergency use of the COVID-19 Vaccine Comirnaty® for the prevention of COVID-19 to include children five through 11 years of age.

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