Blog
RSS FeedPosted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 09 May 2024
Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH
8 May 2024 - Sobi today announced that the European Commission has approved an indication extension for Aspaveli (pegcetacoplan) for ...
Posted by Michael Wonder on 09 May 2024
Government adds two new heart disease treatments on the PBS
9 May 2024 - Australians with different types of cardiomyopathies now have access to new treatments under the Pharmaceutical Benefits Scheme. ...
Posted by Michael Wonder on 09 May 2024
Health Canada approves Zoladex LA for the management of oestrogen receptor positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and peri-menopausal women
7 May 2024 - TerSera Canada today announced that Health Canada has approved a supplemental new drug submission for Zoladex LA ...
Posted by Michael Wonder on 08 May 2024
Avidity Biosciences receives FDA breakthrough therapy designation for delpacibart etedesiran (AOC 1001) for treatment of myotonic dystrophy type 1
8 May 2024 - Delpacibart etedesiran data from MARINA-OLE showed reversal of disease progression in multiple functional measures in DM1 ...
Posted by Michael Wonder on 08 May 2024
Selinexor with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma after 4 or more treatments
8 May 2024 - NICE has published evidence-based recommendations on the use of selinexor (Nexpovio) in combination with dexamethasone for ...
Posted by Michael Wonder on 08 May 2024
First patient begins newly approved sickle cell gene therapy
6 May 2024 - On Wednesday, Kendric Cromer, a 12 year old boy from a suburb of Washington, became the ...
Posted by Michael Wonder on 07 May 2024
Innovent receives NMPA breakthrough therapy designation for IBI34 (anti-Claudin18.2 antibody drug conjugate) as monotherapy for advanced gastric cancer
7 May 2024 - Innovent Biologics announced that the Center for Drug Evaluation of China's National Medical Products Administration has ...
Posted by Michael Wonder on 07 May 2024
iECURE receives FDA fast track designation for ECUR-506 for the treatment of neonatal onset ornithine transcarbamylase deficiency
6 May 2024 - iECURE announced today that it has received fast track designation from the US FDA for ECUR-506, ...
Posted by Michael Wonder on 07 May 2024
Azurity Pharmaceuticals announces FDA approval of Myhibbin (mycophenolate mofetil oral suspension)
6 May 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Myhibbin, the only ready to use mycophenolate ...
Posted by Michael Wonder on 06 May 2024
Merus announces US FDA acceptance and priority review of biologics license application for zenocutuzumab for the treatment of NRG1 positive NSCLC and PDAC
6 May 2024 - If approved, zenocutuzumab will be the first targeted therapy for NRG1 positive cancer. ...
Posted by Michael Wonder on 06 May 2024
MannKind receives US FDA fast track designation for clofazimine inhalation suspension for the treatment of non-tuberculous mycobacterial lung disease
6 May 2024 - MannKind Corporation announced today that the US FDA has granted fast track designation of clofazimine inhalation suspension ...
Posted by Michael Wonder on 06 May 2024
US FDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase)
6 May 2024 - Application based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab ...
Posted by Michael Wonder on 06 May 2024
EMA validates Bristol Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer
6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
Posted by Michael Wonder on 06 May 2024
Taysha Gene Therapies announces regenerative medicine advanced therapy designation granted by US FDA for TSHA-102 in Rett syndrome
2 May 2024 - RMAT designation follows FDA’s review of available safety and efficacy data from the first three patients dosed ...