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RSS FeedPosted by Michael Wonder on 20 Feb 2021
Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the U.S. FDA
19 February 2021 - Pfizer and BioNTech today announced the submission of new data to the U.S. FDA demonstrating the stability ...
Posted by Michael Wonder on 20 Feb 2021
Immunocore’s tebentafusp granted breakthrough therapy designation for unresectable or metastatic uveal melanoma from FDA
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
Posted by Michael Wonder on 19 Feb 2021
Efanesoctocog alfa granted FDA fast track designation for treatment of haemophilia A
18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...
Posted by Michael Wonder on 18 Feb 2021
Additive Orthopaedics announces FDA approval of patient specific talus spacer, first approved in the U.S.
17 February 2021 - Company can now initiate commercial marketing, sale, and distribution of patient specific talus spacer implants. ...
Posted by Michael Wonder on 18 Feb 2021
Coherus BLA filing for adalimumab biosimilar candidate accepted by FDA for review
17 February 2021 - Coherus BioSciences announced that the United States FDA has accepted for review the 351(k) biologics license application ...
Posted by Michael Wonder on 18 Feb 2021
Johnson & Johnson has only a few million COVID-19 vaccine doses in stock as likely launch nears
18 February 2021 - Johnson & Johnson has only a few million doses of its experimental COVID-19 vaccine in its ...
Posted 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 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 ...