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RSS FeedPosted by Michael Wonder on 18 Feb 2021
Astellas and Seagen announce submission of two supplemental biologics license applications to the U.S. FDA for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
18 February 2021 - Submissions will be reviewed under Real-Time Oncology Review based on clinical trials EV-301 and cohort 2 of ...
Posted by Michael Wonder on 18 Feb 2021
Pfizer and BioNTech to supply the European Union with 200 million additional doses of Cominarty
17 February 2021 - New agreement brings total supply to the European Union to 500 million doses, with delivery expected by ...
Posted by Michael Wonder on 18 Feb 2021
Ultragenyx announces approval of Dojolvi (UX007/triheptanoin) in Canada for the treatment of long-chain fatty acid oxidation disorders in adults and children
17 February 2021 - First approved treatment for adult and paediatric patients with long-chain fatty acid oxidation disorders in Canada. ...
Posted 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
Sandoz Canada completes its fifth biosimilar launch with new biosimilar Hyrimoz (adalimumab)
16 February 2021 - Hyrimoz for use in nine indications covered by the reference medicine in the fields of rheumatology, gastro-enterology ...
Posted by Michael Wonder on 17 Feb 2021
Health Canada approves Reblozyl (luspatercept), new class of treatment for adult patients living with myelodysplastic syndromes
16 February 2021 - Reblozyl, an erythroid maturation agent, is the first and only of its kind approved for use in ...
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
Medicines Australia statement on TGA’s provisional approval of AstraZeneca’s COVID-19 vaccine
16 February 2021 - Medicines Australia welcomes the TGA’s decision granting provisional approval of the AstraZeneca/Oxford University COVID-19 vaccine, marking ...
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 ...