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RSS FeedPosted by Michael Wonder on 19 Sep 2024
FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
19 September 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for adult patients with locally ...
Posted by Michael Wonder on 19 Sep 2024
FDA declines to approve Vanda's marketing application for tradipitant in gastroparesis
19 September 2024 - - Vanda Pharmaceuticals today provided an update on its tradipitant development program. ...
Posted by Michael Wonder on 19 Sep 2024
Azitra receives fast track designation for ATR-04 for skin rash from EGFR inhibitors
18 September 2024 - Azitra today announced the US FDA has granted fast track designation for topically applied ATR-04 to treat ...
Posted by Michael Wonder on 19 Sep 2024
Glycomine receives FDA fast track designation for GLM101 for the treatment of PMM2-CDG
18 September 2024 - Glycomine announced today that the US FDA has granted fast track designation for GLM101, a mannose-1-phosphate ...
Posted by Michael Wonder on 19 Sep 2024
ImCheck receives FDA fast track designation for ICT01 in combination with azacitidine and venetoclax in first-line acute myeloid leukaemia for patients unfit for induction chemotherapy treatment
18 September 2024 - ICT01, a humanised anti-butyrophilin 3A monoclonal antibody designed to selectively activate Vγ9Vδ2 T cells, has shown ...
Posted by Michael Wonder on 18 Sep 2024
The ICER developing special report for submission to CMS as part of public comment process on Medicare drug price negotiations
18 September 2024 - Report to reflect legislative specifications in the Inflation Reduction Act and subsequent CMS guidance regarding price ...
Posted by Michael Wonder on 18 Sep 2024
Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
18 September 2024 - New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and ...
Posted by Michael Wonder on 18 Sep 2024
Oncology accelerated approvals are often based on non-comparative trials evaluating response rate
17 September 2024 - Most oncology products granted accelerated approval by the US FDA tend to rely on non-comparative single ...
Posted by Michael Wonder on 17 Sep 2024
BridgeBio announces infigratinib is the first ever investigational therapeutic option for achondroplasia to be awarded breakthrough therapy designation by the FDA
17 September 2024 - Breakthrough therapy designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
17 September 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of ...
Posted by Michael Wonder on 17 Sep 2024
ICER to assess treatment for retinitis pigmentosa
17 September 2024 - Report will be subject of New England CEPAC meeting in April 2025; draft scoping document open ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer
17 September 2024 - Today, the FDA approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for the adjuvant treatment of ...
Posted by Michael Wonder on 17 Sep 2024
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-ALLO1 to treat relapsed/refractory multiple myeloma
16 September 2024 - FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1. ...
Posted by Michael Wonder on 14 Sep 2024
A roadmap for improving Medicare’s application of coverage with evidence development
13 September 2024 - The Centers for Medicare and Medicaid Services’ coverage with evidence development policy allows the agency to provide ...
Posted by Michael Wonder on 14 Sep 2024
US FDA grants RPD designation to Senhwa Biosciences silmitasertib for paediatric neuroblastoma
13 September 2024 - Senhwa Biosciences today announced that its new drug silmitasertib (CX-4945) was granted a rare paediatric disease designation ...