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RSS FeedPosted by Michael Wonder on 28 May 2026
US FDA approves Decnupaz (pivekimab sunirine-pvzy) for treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, an ultra rare and aggressive blood cancer with limited treatment options
27 May 2026 - AbbVie today announced that the US FDA has approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of ...
Posted by Michael Wonder on 28 May 2026
BridgeBio announces FDA acceptance and priority review of NDA for BBP-418 for LGMD2I/R9
27 May 2026 - BridgeBio Pharma today announced the FDA has accepted for filing its new drug application with priority review ...
Posted by Michael Wonder on 28 May 2026
Solu Therapeutics granted FDA fast track designation for STX-0712 for treatment of chronic myelomonocytic leukaemia
27 May 2026 - Solu Therapeutics today announced that the US FDA has granted fast track designation to STX-0712, the company's ...
Posted by Michael Wonder on 27 May 2026
Outlook Therapeutics wins appeal following formal dispute resolution process for ONS-5010/Lytenava (bevacizumab-vikg) company plans to resubmit BLA to the FDA in June 2026
26 May 2026 - Outlook Therapeutics today announced that the US FDA has granted the appeal following completion of the ...
Posted by Michael Wonder on 27 May 2026
FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy
27 May 2026 - Today, the FDA approved pivekimab sunirine-pvzy (Decnupaz, AbbVie), a CD123-directed antibody and alkylating agent conjugate, for ...
Posted by Michael Wonder on 27 May 2026
US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
27 May 2026 - The US FDA has informed AstraZeneca that it will extend the PDUFA date to review additional data ...
Posted by Michael Wonder on 27 May 2026
Dyne Therapeutics announces submission of biologics license application to US FDA for z-rostudirsen in exon 51 Duchenne muscular dystrophy
26 May 2026 - Submission for accelerated approval based on dystrophin as a surrogate outcome. ...
Posted by Michael Wonder on 27 May 2026
Autobahn Therapeutics announces US FDA fast track designation for elunetirom, a CNS directed thyroid hormone receptor agonist, for the adjunctive treatment of bipolar depression
26 May 2026 - Autobahn Therapeutics today announced that the US FDA granted fast track designation to elunetirom, the Company’s lead ...
Posted 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
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 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 ...