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RSS FeedPosted 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 01 May 2026
MRM Health’s lead candidate MH002 granted fast track designation by US FDA for the treatment of mild to moderate ulcerative colitis
30 April 2026 - MRM Health today announced that MH002, the Company’s lead rationally designed live biotherapeutic product candidate, has been ...
Posted by Michael Wonder on 30 Apr 2026
Prolong’s investigational therapy for acute ischaemic stroke, PP-007, receives FDA breakthrough therapy designation
30 April 2026 - Prolong Pharmaceuticals announced today that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has received breakthrough therapy designation ...
Posted by Michael Wonder on 30 Apr 2026
Schedule of Pharmaceutical Benefits - 1 May 2026
1 May 2026 - The May 2026 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
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
First NICE recommended treatment for uncontrolled generalised myasthenia gravis
29 April 2026 - We’ve recommended a new treatment called rozanolixizumab for some adults living with generalised myasthenia gravis whose ...
Posted by Michael Wonder on 30 Apr 2026
Have your say on the framework for consumer engagement in HTA
29 April 2026 - We are developing a framework that sets out guiding principles, focus areas and actions to support ...
Posted by Michael Wonder on 30 Apr 2026
Draft 2026-27 Cost Recovery Implementation Statement for listing medicines on the PBS and designated vaccines on the NIP
30 April 2026 - Consultation on the draft 2026-27 Cost Recovery Implementation Statement (CRIS) for listing medicines on the Pharmaceutical ...
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
ICER releases evidence report on treatment for narcolepsy
29 April 2026 - Oveporexton provides a net health benefit compared to currently available treatments; therapy would be cost effective ...
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 ...