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RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 30 Apr 2026
European Commission approves Henlius and Organon's Poherdy (pertuzumab), the first approved biosimilar to Perjeta (pertuzumab) in Europe
29 April 2026 - Shanghai Henlius Biotech, and Organon today announced the European Commission has granted marketing authorization for Poherdy (pertuzumab) ...
Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review to BeOne Medicines’ Tevimbra in first-line HER2 positive gastro-oesophageal adenocarcinoma
29 April 2026 - BeOne Medicines today announced that the US FDA has granted priority review to a supplemental biologics ...
Posted by Michael Wonder on 30 Apr 2026
Immunome nnounces submission of new drug application to US FDA for varegacestat for the treatment of adults with desmoid tumours
29 April 2026 - Immunome today announced the submission of a new drug application to the US FDA for varegacestat, an ...
Posted by Michael Wonder on 30 Apr 2026
Richter receives European Commission approval for Tuyory, its biosimilar tocilizumab in multiple indications
29 April 2026 - Gedeon Richter announces today that the European Commission granted marketing authorisation for Tuyory, its biosimilar to ...
Posted by Michael Wonder on 30 Apr 2026
Norgine announces European Commission marketing authorisation for Xolremdi (mavorixafor), the first authorised treatment for patients with WHIM syndrome in the European Union
29 April 2026 - Norgine today announced that the European Commission has granted marketing authorisation for mavorixafor as Xolremdi following a ...