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RSS FeedPosted by Michael Wonder on 17 Feb 2021
Axonics receives FDA approval for third generation implantable neurostimulator
16 February 2021 - Axonics Modulation Technologies has received PMA supplement approval from the U.S. FDA for its third generation implantable ...
Posted by Michael Wonder on 17 Feb 2021
Verrica Pharmaceuticals announces FDA filing acceptance of resubmitted new drug application for VP-102 for the treatment of molluscum contagiosum
17 February 2021 - PDUFA goal date assigned is 23 June 2021. ...
Posted by Michael Wonder on 17 Feb 2021
BeiGene announces U.S. FDA acceptance of supplemental new drug application for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
17 February 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa (zanubrutinib) ...
Posted by Michael Wonder on 17 Feb 2021
FDA approves first in the world, first-of-its-kind implant for the treatment of rare bone disease as a humanitarian use device
17 February 2021 - Today, the U.S. FDA approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. ...
Posted by Michael Wonder on 17 Feb 2021
COVID-19 vaccine approval process: does it take too long?
15 February 2021 - Here are answers to some questions about the FDA review panels. ...
Posted by Michael Wonder on 17 Feb 2021
Immortal time bias in observational studies
16 February 2021 - Observational studies are commonly used to evaluate the association between a risk factor or “exposure” and the ...
Posted by Michael Wonder on 17 Feb 2021
FDA grants sotorasib priority review designation for the treatment of patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer
16 February 2021 - FDA target action date is 16 August 2021 ...
Posted by Michael Wonder on 17 Feb 2021
Reflections on a record year for novel device innovation despite COVID-19 challenges
16 February 2021 - As we look ahead this year, it is important to pause and reflect on the important milestones ...
Posted by Michael Wonder on 16 Feb 2021
Jazz Pharmaceuticals completes submission of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia
16 February 2021 - Jazz Pharmaceuticals today announced the completion of the rolling submission for the supplemental new drug application to ...
Posted by Michael Wonder on 16 Feb 2021
Forge Biologics receives FDA fast track, orphan drug, and rare paediatric disease designations for FBX-101 gene therapy for patients with Krabbe disease
16 February 2021 - FBX-101 is a first-in-human gene therapy utilising an adeno-associated virus to deliver a functioning copy of the ...
Posted by Michael Wonder on 16 Feb 2021
After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
16 February 2021 - In response to criticism, a top FDA official maintained that creating a firewall between agency staff ...
Posted by Michael Wonder on 16 Feb 2021
Sesen Bio announces FDA acceptance and priority review of its biologics license application for Vicineum
16 February 2021 - FDA stated it is not currently planning to hold an advisory committee meeting. ...
Posted by Michael Wonder on 16 Feb 2021
Novartis Entresto granted expanded indication in chronic heart failure by FDA
16 February 2021 - Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined ...
Posted by Michael Wonder on 16 Feb 2021
The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA
15 February 2021 - For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has ...
Posted by Michael Wonder on 15 Feb 2021
Targovax receives fast track designation for ONCOS-102
15 February 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in malignant ...