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RSS FeedPosted by Michael Wonder on 20 Apr 2021
COVID-19 vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
20 April 2021 - EMA confirms overall benefit-risk remains positive ...
Posted by Michael Wonder on 20 Apr 2021
LEXEO Therapeutics announces FDA fast track designation granted to LX1001 for the treatment of APOE4 associated Alzheimer’s disease
20 April 2021 - LX1001 is the first investigational gene therapy being evaluated to address the underlying genetics of Alzheimer’s disease. ...
Posted by Michael Wonder on 20 Apr 2021
Alnylam submits new drug application with U.S. FDA for vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults
19 April 2021 - Alnylam has submitted a new drug application to the U.S. FDA for the approval of vutrisiran for ...
Posted by Michael Wonder on 20 Apr 2021
CureVac Swiss initiates rolling submission process for mRNA-based COVID-19 vaccine candidate, CVnCoV, with Swissmedic
19 April 2021 - Review process started with submission of first CVnCoV data package. ...
Posted by Michael Wonder on 20 Apr 2021
Pfizer and BioNTech to supply the European Union with 100 million additional doses of Comirnaty
19 April 2021 - European Union exercises option under previous agreement to order 100 million additional doses of Comirnaty, bringing total ...
Posted by Michael Wonder on 20 Apr 2021
Amgen's investigational targeted treatment bemarituzumab granted breakthrough therapy designation
19 April 2021 - Designation is supported by results from the Phase 2 FIGHT trial. ...
Posted by Michael Wonder on 19 Apr 2021
FDA issues final rule removing certain software from medical device regulations
19 April 2021 - The US FDA has issued a final rule making that eliminates certain software intended to transfer, ...
Posted by Michael Wonder on 19 Apr 2021
Fauci says he expects a decision Friday on whether the U.S. can resume using Johnson & Johnson’s vaccine
18 April 2021 - A decision about whether to resume administering the Johnson & Johnson COVID-19 vaccine should come this ...
Posted by Michael Wonder on 19 Apr 2021
Darzalex SC becomes the first and only Health Canada approved treatment for patients with newly diagnosed light chain amyloidosis, a rare disease
19 April 2021 - Darzalex SC combination regimen is supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher haematologic ...
Posted by Michael Wonder on 19 Apr 2021
United Therapeutics announces submission of Tvyaso DPI new drug application to FDA
19 April 2021 - Priority review voucher applied to the submission. ...
Posted by Michael Wonder on 19 Apr 2021
Agenus submits balstilimab biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
19 April 2021 - Submission has been made for review under the accelerated approval pathway ...
Posted by Michael Wonder on 19 Apr 2021
ALK gains paediatric approval for its ragweed SLIT tablet in the USA
19 April 2021 - The approval is based on data from one of the largest-ever paediatric SLIT-tablet trials, involving over 1,000 ...
Posted by Michael Wonder on 19 Apr 2021
Seagen and Astellas announce U.S. FDA acceptance of two supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
19 April 2021 - Australia and Canada regulators will review applications as part of FDA’s Project Orbis. ...
Posted by Michael Wonder on 19 Apr 2021
European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma
19 April 2021 - Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone ...
Posted by Michael Wonder on 18 Apr 2021
Greg Hunt confirms ‘high interest’ in producing mRNA vaccines onshore
18 April 2021 - Australia is interested in producing a cutting-edge form of vaccines in Australia, after the nation’s rollout was ...