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RSS FeedPosted by Michael Wonder on 24 May 2026
FDA grants accelerated approval to Gilead’s Hepcludex (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus
22 May 2026 - Approval introduces the first FDA approved therapy for this disease with limited treatment options and high ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2 directed antibody drug conjugate for first-line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - AstraZeneca and Daiichi Sankyo’s Datroway is the only TROP2-directed antibody drug conjugate to prolong overall survival in ...
Posted by Michael Wonder on 22 May 2026
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple negative breast cancer
22 May 2026 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adult patients with unresectable or metastatic ...
Posted by Michael Wonder on 22 May 2026
FDA approves first treatment for chronic hepatitis delta virus infection
22 May 2026 - Today, the US FDA approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus infection in adults ...
Posted by Michael Wonder on 22 May 2026
Vertex announces new drug submission for suzetrigine has been accepted for review by Health Canada for the treatment of moderate to severe acute pain in adults
21 May 2026 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review a new drug submission for ...
Posted by Michael Wonder on 22 May 2026
FDA approves new Guardant360 Liquid CDx, the largest FDA approved liquid biopsy panel with a 100x expanded footprint
20 May 2026 - Guardant Health today announced that the US FDA has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic ...
Posted by Michael Wonder on 21 May 2026
Bayer’s Kerendia (finerenone) granted priority review of supplemental new drug application by US FDA for treatment of adults with type 1 diabetes and chronic kidney disease
21 May 2026 - Bayer announced today that the US FDA accepted its supplemental new drug application and granted priority review ...
Posted by Michael Wonder on 20 May 2026
FDA official offers examples of RWE being used to secure drug approval
19 May 2026 - An official from the US FDA on Monday presented three case studies demonstrating how sponsors effectively ...
Posted by Michael Wonder on 20 May 2026
ImmunityBio announces FDA acceptance of supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease
19 May 2026 - ImmunityBio today announced that the US FDA has accepted for review the supplemental biologics license application for ...
Posted by Michael Wonder on 20 May 2026
FDA accepts sNDA and grants priority review to Aqneursa for ataxia-telangiectasia
19 May 2026 - IntraBio today announced that the US FDA has accepted for review its supplemental new drug application ...
Posted by Michael Wonder on 20 May 2026
TrumpRx adds generic drugs, with Mark Cuban, GoodRx and Amazon
18 May 2026 - President Trump announced the addition of 600 medicines to his online drugstore as he appeals to Americans ...
Posted by Michael Wonder on 19 May 2026
US FDA accepts Viatris new drug application for fast-acting meloxicam for the treatment of moderate to severe acute pain
18 May 2026 - Viatris today announced that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 19 May 2026
Bayer granted priority review by US FDA for asundexian in patients after a non-cardioembolic ischaemic stroke or transient ischaemic attack
19 May 2026 - Bayer today announced that the US FDA has accepted the company’s new drug application and granted priority ...
Posted by Michael Wonder on 19 May 2026
FDA approves Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), first biosimilars to Simponi (golimumab) and Simponi Aria (golimumab)
18 May 2026 - Accord BioPharma announced today that the US FDA has approved Immgolis (golimumab-sldi), a biosimilar to Simponi ...