Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2024
Inside the quiet strategy pharma giants are using to fend off generics and drive up the cost of medicines
18 September 2024 - Amid debate over potential abuse of the US patent system by the pharmaceutical industry, moves by ...
Posted by Michael Wonder on 21 Sep 2024
Voucher program notches win as clock ticks
20 September 2024 - The FDA’s priority review voucher program for rare paediatric diseases is set to lapse on 30 September ...
Posted by Michael Wonder on 21 Sep 2024
FDA fast track designation for narmafotinib in advanced pancreatic cancer
19 September 2024 - Amplia Therapeutics is pleased to announce that the US FDA has granted fast track designation to Amplia's ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
20 September 2024 - Today, the FDA approved isatuximab-irfc (Sarclisa, Sanofi-Aventis) with bortezomib, lenalidomide, and dexamethasone for adults with newly ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves first treatment for Niemann-Pick disease, type C
20 September 2024 - Today, the US FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type ...
Posted 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
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
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 ...