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RSS FeedPosted 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
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to ...
Posted by Michael Wonder on 28 May 2024
Vera Therapeutics receives US FDA breakthrough therapy designation for atacicept in immunoglobulin A nephropathy
28 May 2024 - Vera Therapeutics today announced that the US FDA has granted breakthrough therapy designation to atacicept for the ...
Posted by Michael Wonder on 28 May 2024
Vasomune Therapeutics receives US FDA fast track designation for novel investigational medicine AV-001
28 May 2024 - Vasomune Therapeutics has announced today that the US FDA granted fast track designation for AV-001 for the ...
Posted by Michael Wonder on 28 May 2024
Fresenius announces FDA acceptance for review of denosumab biosimilar application
27 May 2024 - Fresenius announced today that the US FDA has accepted for review the company’s biologics license application ...
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 28 May 2024
Telix submits NDA for new prostate cancer imaging agent
27 May 2024 - Telix Pharmaceuticals today announces it has submitted a new drug application to the US FDA for ...
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 25 May 2024
Sobi receives US FDA fast track designation for emapalumab-lzsg being investigated in macrophage activation syndrome
24 May 2024 - Sobi North America today announced that the US FDA has granted fast track designation to emapalumab-lzsg being ...
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 23 May 2024
Advancing access to cell and gene therapies in Medicaid
22 May 2024 - The Biden administration’s stated priority to increase access to novel cell and gene therapeutics while controlling their ...
Posted by Michael Wonder on 23 May 2024
COTA announces extended collaboration with FDA to advance the use of real world data in cancer research
22 May 2024 - Today, COTA announced an extension of its research collaboration with the US FDA Oncology Center of Excellence. ...