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RSS FeedPosted by Michael Wonder on 03 Sep 2021
FDA acceptance for filing of new drug application for trientine tetrahydrochloride for the treatment of Wilson’s disease
2 September 2021 - New drug application supported by positive data from Phase 3 CHELATE clinical trial. ...
Posted by Michael Wonder on 02 Sep 2021
Novartis gets FDA fast track designation for LNA043 in knee osteoarthritis
2 September 2021 - Novartis AG on Thursday said the U.S. FDA granted fast track designation to LNA043 for the ...
Posted by Michael Wonder on 02 Sep 2021
House Committees demand FDA records on Alzheimer’s drug approval
2 September 2021 - The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter. ...
Posted by Michael Wonder on 02 Sep 2021
FDA reaches milestone in competitive generic therapy drug approvals
2 September 2021 - This week, the FDA reached the milestone of approving more than 100 generic drug applications with a ...
Posted by Michael Wonder on 02 Sep 2021
Natco Pharma (Canada) announces the launch of Nat-Lenalidomide capsules, the first generic alternative to Revlimid
1 September 2021 - Nat-Lenalidomide expands affordable treatment options for patients with multiple myeloma and patients with transfusion-dependent anaemia due to ...
Posted by Michael Wonder on 02 Sep 2021
FDA to hold Advisory Committee meeting to discuss Pfizer-BioNTech’s application for COVID-19 booster
2 September 2021 - Today, the U.S. FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory ...
Posted by Michael Wonder on 02 Sep 2021
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
2 September 2021 - Based on current evidence, there is no urgent need for the administration of booster doses of vaccines ...
Posted by Michael Wonder on 02 Sep 2021
Moderna announces submission of initial data to US FDA for its COVID-19 vaccine booster
1 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the ...
Posted by Michael Wonder on 02 Sep 2021
COVID-19 vaccine weekly safety report (2 September 2021)
2 September 2021 - To 29 August 2021, over 19 million vaccine doses have been given in Australia – approximately 12 ...
Posted by Michael Wonder on 01 Sep 2021
Coherus and Junshi Biosciences announce completion of rolling BLA submission to U.S. FDA for toripalimab for the treatment of nasopharyngeal carcinoma
1 September 2021 - Junshi Biosciences and Coherus Biosciences announced today the completion of the rolling submission of the biologics ...
Posted by Michael Wonder on 01 Sep 2021
FDA approves zanubrutinib for Waldenström’s macroglobulinaemia
1 September 2021 - On 31 August 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with ...
Posted by Michael Wonder on 01 Sep 2021
In2Bones receives FDA clearance for pre-surgery OrthoPlanify patient specific planning software and 3D printed cutting guides for Quantum Total Ankle System
1 September 2021 - In2Bones Global today announces the FDA clearance of OrthoPlanify patient-specific planning software and 3D printed cutting ...
Posted by Michael Wonder on 01 Sep 2021
Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System
1 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Golden Isles Pedicle ...
Posted by Michael Wonder on 01 Sep 2021
FDA requires warnings about increased risk of serious heart related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
1 September 2021 - Based on a completed U.S. FDA review of a large randomised safety clinical trial, we have concluded ...
Posted by Michael Wonder on 01 Sep 2021
FDA approves drug for schizophrenia to be administered at a six month interval
1 September 2021 - The FDA has approved Invega Hafyera (paliperidone palmitate) extended-release injectable suspension to treat schizophrenia in certain ...