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RSS FeedPosted 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 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test ...
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 04 May 2026
New first in class therapy for chronic graft versus host disease approved in Australia
3 May 2026 - Specialised Therapeutics is pleased to announce that Niktimvo (axatilimab) has been approved for use in Australia ...
Posted by Michael Wonder on 03 May 2026
Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic
1 May 2026 - Apotex today announced that Health Canada has approved Apo‑Semaglutide Injection, a generic equivalent of Ozempic (semaglutide injection). ...
Posted by Michael Wonder on 03 May 2026
Novartis receives Health Canada approval for Fabhalta oral treatment for adults with C3G
1 May 2026 - Novartis Pharmaceuticals Canada announced today that Health Canada has granted a Notice of Compliance for Fabhalta (iptacopan ...
Posted by Michael Wonder on 03 May 2026
Incyte announces FDA Approval of Jakafi XR (ruxolitinib) extended release tablets for the treatment of myelofibrosis, polycythemia vera and graft versus host disease
1 May 2026 - Jakafi XR will be available for pharmacy orders by 8 May 2026. ...
Posted by Michael Wonder on 02 May 2026
MHRA approves Linerixibat (Lynavoy) for the treatment of itch due to biliary tract disease
1 May 2026 - The MHRA has today approved Linerixibat (Lynavoy) for use to treat an itch in adults with primary biliary cholangitis. ...
Posted by Michael Wonder on 02 May 2026
Stelara paediatric Crohn’s disease FDA approval J&J statement
1 May 2026 - On 15 April 2026, the US FDA approved Stelara (ustekinumab) for the treatment of patients two ...
Posted by Michael Wonder on 02 May 2026
Arrowhead Pharmaceuticals receives TGA approval of Redemplo (plozasiran) in Australia, expanding global access for patients with familial chylomicronaemia syndrome
1 May 2026 - The approval in Australia is based on positive results from the Phase 3 PALISADE study where ...
Posted by Michael Wonder on 01 May 2026
FDA approves vepdegestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
1 May 2026 - Today, the FDA approved vepdegestrant (Veppanu, Arvinas), a heterobifunctional protein degrader, for adults with oestrogen receptor ...
Posted by Michael Wonder on 01 May 2026
OS Therapies announces EMA initiates rolling review of conditional marketing authorisation application for OST-HER2 in the prevention or delay of recurrence in fully resected pulmonary metastatic osteosarcoma
30 April 2026 - OS Therapies today announced that the EMA's Committee for Advanced Therapy, in conjunction with the CHMP and ...
Posted by Michael Wonder on 01 May 2026
FDA approves first non-antipsychotic drug to treat agitation associated with dementia
30 April 2026 - The US FDA today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets ...
Posted by Michael Wonder on 30 Apr 2026
Xbrane submits ranibizumab biosimilar candidate to FDA
29 April 2026 - Xbrane Biopharma has submitted an application for approval to the US FDA for its biosimilar candidate ...