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RSS FeedPosted by Michael Wonder on 24 Jan 2021
The stakes for choosing the right FDA commissioner couldn’t be higher
24 January 2021 - An independent, credible, science led Food and Drug Administration has long been vital to America’s public, ...
Posted by Michael Wonder on 23 Jan 2021
FDA approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis
22 January 2021 - Lupkynis is the first FDA approved oral therapy for lupus nephritis, a condition that causes irreversible kidney ...
Posted by Michael Wonder on 22 Jan 2021
FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma
22 January 2021 - Today the FDA approved the combination of nivolumab (Opdivo, Bristol-Myers) and cabozantinib (Cabometyx, Exelixis) as ...
Posted by Michael Wonder on 22 Jan 2021
Menarini receives European Commission approval of Elzonris (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm
21 January 2021 - Elzonris is the first approved treatment for patients with blastic plasmacytoid dendritic cell neoplasm, and the ...
Posted by Michael Wonder on 22 Jan 2021
Incyte announces acceptance and priority review of BLA for retifanlimab as a potential treatment for patients with squamous cell carcinoma of the anal canal
21 January 2021 - Incyte today announced that the U.S. FDA has accepted for priority review its biologics license application for ...
Posted by Michael Wonder on 21 Jan 2021
FDA approves first extended release, injectable drug regimen for adults living with HIV
21 January 2021 - The U.S. FDA today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the ...
Posted by Michael Wonder on 21 Jan 2021
Italy ponders suing Pfizer for delays in coronavirus vaccine
21 January 2021 - Italy's coronavirus commissioner is pressing ahead with plans to take legal action against Pfizer after the ...
Posted by Michael Wonder on 21 Jan 2021
Biden appoints veteran Woodcock as interim FDA commissioner
21 January 2021 - Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden ...
Posted by Michael Wonder on 21 Jan 2021
FDA grants priority review to Genentech’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
21 January 2021 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 21 Jan 2021
Human medicines: highlights of 2020
21 January 2021 - EMA has published an PDF iconoverview of its key recommendations in 2020 on the authorisation and ...
Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...
Posted by Michael Wonder on 21 Jan 2021
Doptelet (avatrombopag) approved in the EU for treatment of ITP
20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...
Posted by Michael Wonder on 20 Jan 2021
TGA grants additional provisional determination for a COVID-19 vaccine
20 January 2021 - The TGA, part of the Department of Health, has granted a provisional determination to Biocelect (on ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...
Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...