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RSS FeedPosted by Michael Wonder on 30 May 2024
FDA grants priority review to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
29 May 2024 - The target action date for the FDA decision is 27 November 2024. ...
Posted by Michael Wonder on 29 May 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
29 May 2024 - Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant ...
Posted by Michael Wonder on 29 May 2024
FDA grants accelerated approval to selpercatinib for paediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumours
29 May 2024 - Today, the FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for certain paediatric patients two ...
Posted by Michael Wonder on 29 May 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
29 May 2024 - Approval based on results from CheckMate-901, the first Phase 3 trial in this patient population with an ...
Posted by Michael Wonder on 29 May 2024
Zanubrutinib in combination with obinutuzumab for the treatment of patients with relapsed or refractory B-cell follicular lymphoma after two or more treatments
28 May 2024 - NICE is unable to make a recommendation on the use of zanubrutinib (Brukinsa) in combination with obinutuzumab ...
Posted by Michael Wonder on 29 May 2024
Dabrafenib mesylate in combination with trametinib dimethyl sulphoxide for the treatment of children and adolescents with BRAF V600E mutation positive glioma
29 May 2024 - NICE has published final evidence-based recommendations on the use of dabrafenib mesylate (Finlee) in combination with ...
Posted by Michael Wonder on 28 May 2024
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study. ...
Posted by Michael Wonder on 25 May 2024
FDA Advisory Committee Panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option
23 May 2024 - Shield remains on track to become the first FDA approved blood test that meets performance requirements for ...
Posted by Michael Wonder on 25 May 2024
Verastem Oncology announces the initiation of a rolling submission of NDA to FDA seeking accelerated approval of avutometinib and defactinib combination for the treatment of adult patients with recurrent KRAS mutant low grade serous ovarian cancer
24 May 2024 - Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of ...
Posted by Michael Wonder on 23 May 2024
Jiangsu to ‘reapply for US approval of rivoceranib combo therapy ASAP’
23 May 2024 - Hangseo Hengrui Pharmaceuticals said Thursday that it would meet with the US FDA as soon as ...
Posted by Michael Wonder on 23 May 2024
Theriva Biologics announces fast track designation granted by the US FDA for VCN-01 for the treatment of metastatic pancreatic cancer
23 May 2024 - Theriva Biologics today announced that the US FDA has granted fast track designation to lead clinical candidate ...
Posted by Michael Wonder on 22 May 2024
Atara Biotherapeutics submits tabalecleucel (tab-cel) biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease with US FDA
20 May 2024 - First allogeneic T-cell therapy BLA submission to US FDA. ...
Posted by Michael Wonder on 22 May 2024
FDA grants breakthrough therapy designation to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
21 May 2024 - The designation is based on Phase 3 INAVO120 results, showing the inavolisib based regimen more than doubled ...
Posted by Michael Wonder on 21 May 2024
Bristol Myers Squibb announces updated action date by the US FDA for subcutaneous nivolumab (nivolumab and hyaluronidase)
21 May 2024 - Updated PDUFA goal date of 29 December 2024. ...
Posted by Michael Wonder on 20 May 2024
Will Erbitux’s reimbursement be expanded to first-line treatment of colorectal cancer?
17 May 2024 - Attention is on whether Merck's colorectal cancer drug, Erbitux (cetuximab), can expand its reimbursement following the ...