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RSS FeedPosted by Michael Wonder on 24 Mar 2021
REN001 granted fast track designation by FDA for patients with primary mitochondrial myopathies
24 March 2021 - Reneo Pharmaceuticals today announced that the United States FDA granted fast track designation to REN001 for the ...
Posted by Michael Wonder on 24 Mar 2021
FDA grants breakthrough device designation to Tempus’ atrial fibrillation ECG analysis platform, developed in collaboration with Geisinger
24 March 2021 - Tempus today announced that the U.S. FDA has granted the company breakthrough device designation for its ECG ...
Posted by Michael Wonder on 24 Mar 2021
Biden’s choice and FDA’s loosening standards of evidence
23 March 2021 - The US Food and Drug Administration is widely considered the world’s premier regulator of drugs and devices, ...
Posted by Michael Wonder on 24 Mar 2021
FDA authorises LetsGetChecked’s home collection coronavirus (COVID-19) test for direct to consumer purchase
24 March 2021 - The direct to consumer test is now authorised by the FDA to sell directly to consumers online ...
Posted by Michael Wonder on 24 Mar 2021
Seqirus ready to reinforce Canada's influenza pandemic preparedness plans
23 March 2021 - Health Canada's approval of Foclivia (an adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine) meets key requirement ...
Posted by Michael Wonder on 24 Mar 2021
Health Canada says AstraZeneca shot is safe as U.S. questions vaccine's clinical trial data
23 March 2021 - U.S. regulator says AstraZeneca may have included 'outdated' data when releasing clinical trial results. ...
Posted by Michael Wonder on 24 Mar 2021
DoorDash launches on-demand delivery of COVID-19 PCR test collection kits through partnerships with Vault Health and Everlywell
22 March 2021 - New partnerships make same-day delivery of FDA authorised COVID-19 test collection kits widely available to consumers across ...
Posted by Michael Wonder on 24 Mar 2021
Super flu vaccine gets the go-ahead
24 March 2021 - A new type of cell-based influenza vaccine is available this winter that promises to be significantly ...
Posted by Michael Wonder on 23 Mar 2021
AstraZeneca vaccine trial data questions raised by US drug agency
23 March 2021 - Promising results announced on Monday from AstraZeneca’s American vaccine trials may have relied on an incomplete ...
Posted by Michael Wonder on 23 Mar 2021
Health Canada approves Kesimpta, the first and only self-administered targeted B-cell therapy for relapsing remitting multiple sclerosis
23 March 2021 - Approval is based on two Phase 3 studies (ASCLEPIOS I & II) demonstrating significant reductions in risk ...
Posted by Michael Wonder on 23 Mar 2021
Indian cancer drug manufacturer to pay $50 million for concealing and destroying records in advance of FDA inspection
23 March 2021 - Indian drug manufacturer Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture ...
Posted by Michael Wonder on 23 Mar 2021
Novo Nordisk receives refusal to file letter for once weekly semaglutide 2 mg for the treatment of type 2 diabetes
22 March 2021 - Novo Nordisk today announced that the US FDA has issued a refusal to file letter covering the ...
Posted by Michael Wonder on 23 Mar 2021
Optellum receives FDA clearance for the world’s first AI-powered clinical decision support software for early lung cancer diagnosis
23 March 2021 - Virtual Nodule Clinic empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is ...
Posted by Michael Wonder on 23 Mar 2021
Melbourne made COVID-19 vaccine now available
23 March 2021 - The Melbourne manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving ...
Posted by Michael Wonder on 23 Mar 2021
Pacira announces FDA approval of supplemental new drug application for Exparel (bupivacaine liposome injectable suspension) in paediatric patients
22 March 2021 - Exparel is the first and only FDA approved long-acting local analgesic for children aged six and over. ...