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RSS FeedPosted by Michael Wonder on 17 May 2026
New medicines may be out of reach of PBS patients as Australia fails to adapt to ‘seismic market shifts’
18 May 2026 - Donald Trump’s medicines prices policy is causing global market disruption even as Australia’s broken approval processes leave ...
Posted by Michael Wonder on 15 May 2026
Alloplex Biotherapeutics receives FDA fast track designation for Suplexa in colorectal cancer indication
13 May 2026 - Alloplex Biotherapeutics announces that the US FDA has granted fast track designation to Suplexa for the treatment ...
Posted by Michael Wonder on 15 May 2026
Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes
15 May 2026 - Sandoz today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda ...
Posted by Michael Wonder on 15 May 2026
FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
15 May 2026 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo) for two separate indications in adults ...
Posted by Michael Wonder on 15 May 2026
FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
15 May 2026 - Today, the FDA approved atezolizumab (Tecentriq, Genentech) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) as adjuvant ...
Posted by Michael Wonder on 15 May 2026
SMC - May 2026 decisions
11 May 2026 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 15 May 2026
Wegovy and Mounjaro for weight loss not funded
14 May 2026 - PHARMAC has assessed the application to fund Wegovy for weight loss and added it to our ...
Posted by Michael Wonder on 15 May 2026
Apotex launches Apo‑Semaglutide Injection, a generic equivalent of Ozempic, in Canada
14 May 2026 - Apotex today announced the commercial launch of Apo‑Semaglutide Injection – a generic equivalent of Ozempic. ...
Posted by Michael Wonder on 15 May 2026
Routine NHS access to spinal muscular atrophy treatments offers new hope for patients and families
14 May 2026 - People living with spinal muscular atrophy in England are set to gain routine access to two potentially ...
Posted by Michael Wonder on 15 May 2026
Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer
14 May 2026 - Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer. ...
Posted by Michael Wonder on 15 May 2026
INmune Bio receives FDA fast track designation for XPro1595 in early Alzheimer's disease
14 May 2025 - INmune Bio today announced that the US FDA has granted fast track designation to XPro (pegipanermin), the ...
Posted by Michael Wonder on 13 May 2026
FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
13 May 2026 - Today, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology) with ...
Posted by Michael Wonder on 13 May 2026
FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
13 May 2026 - Today, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), a BCL-2 inhibitor, for adults ...
Posted by Michael Wonder on 13 May 2026
European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors
13 May 2026 - Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication ...
Posted by Michael Wonder on 13 May 2026
Kyverna Therapeutics announces initiation of rolling SPS BLA submission
12 May 2026 - The Company has initiated its rolling BLA submission, seeking priority review under the program's regenerative medicine advanced ...