Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2024
The rare paediatric disease voucher program creates new treatments. I have new data to prove it.
2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...
Posted by Michael Wonder on 03 Jul 2024
"99mTc-maraciclatide" granted FDA fast track designation for the diagnosis of superficial peritoneal endometriosis
2 July 2024 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as a ...
Posted by Michael Wonder on 02 Jul 2024
FDA approves treatment for adults with Alzheimer’s disease
2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...
Posted by Michael Wonder on 02 Jul 2024
ICER publishes evidence report on treatment for anaemia in myelodysplastic syndrome
2 July 2024 - There are significant uncertainties regarding long term efficacy and safety of imetelstat; treatment would achieve common ...
Posted by Michael Wonder on 02 Jul 2024
FDA breakthrough therapy designation reduced late-stage drug development time
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
Posted by Michael Wonder on 02 Jul 2024
Longboard Pharmaceuticals receives breakthrough therapy designation for bexicaserin
1 July 2024 - Longboard Pharmaceuticals today announced that the FDA has granted breakthrough therapy designation for its investigational drug ...
Posted by Michael Wonder on 02 Jul 2024
SpringWorks Therapeutics completes submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
1 July 2024 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application to ...
Posted by Michael Wonder on 02 Jul 2024
Syncromune granted FDA fast track designation for SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer
1 July 2024 - Syncromune today announced that the US FDA has granted fast track designation for SYNC-T SV-102 therapy, its ...
Posted by Michael Wonder on 01 Jul 2024
Neurocrine Biosciences announces US FDA accepts new drug applications and grants priority review for crinecerfont for paediatric and adult patients with CAH
1 July 2024 - PDUFA target action dates in late December 2024. ...
Posted by Michael Wonder on 01 Jul 2024
FDA opens doors for more treatments for rare diseases through the new START Pilot Program
27 June 2024 - We are at a turning point in understanding the science that is opening doors to rare disease ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 01 Jul 2024
FDA grants approval for Eylea biosimilar FYB203/Azhantive (aflibercept-mrbb)
28 June 2024 - Formycon and its licensing partner Klinge Biopharma announce that the US FDA today approved FYB203/Azhantive (aflibercept-mrbb), ...
Posted by Michael Wonder on 01 Jul 2024
FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialised by Sandoz in US
1 July 2024 - FDA granted provisional determination for interchangeability designation for Pyzchiva. ...
Posted by Michael Wonder on 29 Jun 2024
Tubulis receives FDA fast track designation for antibody drug conjugate candidate TUB-040 in platinum-resistant ovarian cancer
27 June 2024 - Designation for TUB-040 in platinum-resistant ovarian cancer is based on preclinical data in a range of models, ...
Posted by Michael Wonder on 29 Jun 2024
Abdera Therapeutics announces FDA fast track designation for ABD-147, a next generation precision radiopharmaceutical therapy, for the treatment of patients with extensive-stage small cell lung cancer
27 June 2024 - Abdera Therapeutics today announced that the US FDA has granted fast track designation to ABD-147 for the ...