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RSS FeedPosted by Michael Wonder on 09 Mar 2026
FDA takes further steps to streamline biosimilar development and make medicines more affordable
9 March 2026 - The US FDA today announced another major step in its initiative to streamline the development of biosimilar ...
Posted by Michael Wonder on 09 Mar 2026
ICER to assess treatment for Parkinson’s disease
9 March 2026 - Report will be subject of CTAF meeting in October 2026; draft scoping document open to public ...
Posted by Michael Wonder on 09 Mar 2026
Ipsen voluntarily withdraws Tazverik (tazemetostat) in follicular lymphoma and epithelioid sarcoma
9 March 2026 - Ipsen announced today that it is voluntarily withdrawing Tazverik (tazemetostat) in all indications from all Ipsen ...
Posted by Michael Wonder on 09 Mar 2026
Enhertu granted priority review in the US as post-neoadjuvant treatment for patients with HER2 positive early breast cancer
9 March 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease ...
Posted by Michael Wonder on 08 Mar 2026
Incyte announces the European Commission approval of Zynyz (retifanlimab) for the first-line treatment of advanced squamous cell carcinoma of the anal canal
6 March 2026 - The EC approval is based on results of the POD1UM-303 study which showed that adult patients with ...
Posted by Michael Wonder on 08 Mar 2026
Ottawa should allow all drugs approved in the EU and US to be marketed in Canada
7 March 2026 - The FederalGovernment plans to speed up some drug approvals in Canada by allowing Health Canada to ...
Posted by Michael Wonder on 07 Mar 2026
FDA official offers insights on agency’s criteria for real world data in regulatory submissions
6 March 2026 - The US FDA will consider several factors when determining whether to accept real world data and ...
Posted by Michael Wonder on 07 Mar 2026
US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis
6 March 2026 - Significantly more patients treated with once daily, oral Sotyktu achieved an ACR20 response compared with placebo at ...
Posted by Michael Wonder on 07 Mar 2026
Trump’s drive to get Europe to pay more for drugs creates uncertainty for countries, patients
2 March 2026 - Pharma is also eager to see the region increase spending on medicines. ...
Posted by Michael Wonder on 06 Mar 2026
A month in, TrumpRx falls short of president’s grand promises
5 March 2026 - Few drugs, uneven savings mark early days of Trump’s discount medicines website. ...
Posted by Michael Wonder on 06 Mar 2026
HLS Therapeutics announces Nilemdo (bempedoic acid) is now available in Canada for the reduction of LDL-cholesterol in patients at risk of cardiovascular disease
5 March 2026 - HLS Therapeutics today announced the commercial launch of Nilemdo (bempedoic acid) in Canada. Nilemdo is now available ...
Posted by Michael Wonder on 06 Mar 2026
Roche's Columvi, Takeda's Fruzaqla pass first review for Korea insurance coverage
5 March 2026 - Roche's DLBCL treatment Columvi (glofitamab) and Takeda's metastatic colorectal cancer treatment Fruzaqla (fruquintinib) have cleared the ...
Posted by Michael Wonder on 05 Mar 2026
FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
5 March 2026 - Today, the FDA approved teclistamab (Tecvayli, Janssen Biotech) in combination with daratumumab hyaluronidase-fihj for adult patients ...
Posted by Michael Wonder on 05 Mar 2026
New multi-indication PBS listing for two immunotherapy treatments from March 2026
1 March 2026 - Bristol Myers Squibb Australia confirms that Opdivo (nivolumab) and Yervoy (ipilimumab) will be listed on the ...
Posted by Michael Wonder on 05 Mar 2026
PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026
4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...