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RSS FeedPosted by Michael Wonder on 08 May 2026
FDA grants seventh approval under the National Priority Voucher Pilot Program
8 May 2026 - The US FDA today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion ...
Posted by Michael Wonder on 08 May 2026
Bristol Myers Squibb receives European Commission approval of Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis in adults
8 May 2026 - Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone ...
Posted by Michael Wonder on 08 May 2026
Update on FDA priority review of Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease
8 May 2026 - Eisai and Biogen today announced that the US FDA has extended the review period by three months ...
Posted by Michael Wonder on 08 May 2026
Rznomics announces US FDA regenerative medicine advanced therapy designation granted to RZ-001 for hepatocellular carcinoma
8 May 2026 - RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, ...
Posted by Michael Wonder on 07 May 2026
Armata Pharmaceuticals secures FDA fast track designation for AP-SA02
7 May 2026 - Armata Pharmaceuticals today announced that the US FDA has granted fast track designation to AP-SA02, the Company's ...
Posted by Michael Wonder on 07 May 2026
Partner Therapeutics announces receipt of FDA Commissioner's National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
6 May 2026 - Partner Therapeutics today announced that the US FDA has awarded a Commissioner's National Priority Voucher pilot program ...
Posted by Michael Wonder on 07 May 2026
Diakonos Oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma
6 May 2026 - Diakonos Oncology announced today that the US FDA has granted fast track designation to DOC1021, the ...
Posted by Michael Wonder on 06 May 2026
ICER publishes protocol for annual launch price and access report
4 May 2026 - The ICER posted a protocol today outlining how it will conduct its second annual analysis titled the ...
Posted by Michael Wonder on 06 May 2026
Healyth Canada authorised Lilly's Kisunla (donanemab), a new treatment for early Alzheimer's disease
4 May 2026 - Today, after more than 35 years of commitment to advancing Alzheimer's research, Lilly Canada announced Health Canada's ...
Posted by Michael Wonder on 06 May 2026
Norgine welcomes TGA registration in Australia of Pedmarqsi (sodium thiosulphate anhydrous) for the prevention of cisplatin-induced hearing loss in children
6 May 2026 - Norgine is pleased to announce that Pedmarqsi (sodium thiosulphate anhydrous) has been registered by the Australian TGA ...
Posted by Michael Wonder on 05 May 2026
FDA grants fast track designation for CS-1103, a first in class small molecule to reverse acute intoxication from fentanyl
5 May 2026 - Clear Scientific announced today that the US FDA has granted its lead asset, CS-1103, fast track designation ...
Posted by Michael Wonder on 05 May 2026
Spinogenix receives US FDA fast track designation for tazbentetol for the treatment of ALS
5 May 2026 - Spinogenix today announced that the US FDA has granted fast track designation to tazbentetol for the ...
Posted by Michael Wonder on 05 May 2026
Satellite Bio announces FDA rare paediatric disease designation for SB-101 for the treatment of urea cycle disorders
4 May 2026 - Satellite Biosciences today announced that the US FDA has granted rare paediatric disease designation for SB-101 for ...
Posted by Michael Wonder on 05 May 2026
Expert says treatment relieves children's suffering and saves hospital resources
5 May 2026 - The family of an eight year old Sunshine Coast girl is petitioning the federal government to ...
Posted by Michael Wonder on 05 May 2026
Atossa Therapeutics receives FDA rare paediatric disease designation for (Z)-endoxifen for McCune-Albright syndrome
4 May 2026 - Atossa Therapeutics today announced that the US FDA has granted rare paediatric disease designation to (Z)-endoxifen for ...