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RSS FeedPosted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 10 May 2024
Novartis receives FDA breakthrough therapy designation for Scemblix in first-line CML
10 May 2024 - Breakthrough therapy designation was granted based on positive data from the Phase 3 ASC4FIRST study, in which ...
Posted by Michael Wonder on 10 May 2024
Celltrion USA's adalimumab-aaty biosimilar to Humira now available at low wholesale acquisition cost
9 May 2024 - Adalimumab-aaty will be priced at an 85% discount to Humira (adalimumab). ...
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
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
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 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
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 ...
Posted by Michael Wonder on 02 May 2024
Amolyt Pharma granted FDA fast track designation for eneboparatide for the treatment of hypoparathyroidism
2 May 2024 - Amolyt Pharma today announced that eneboparatide, its lead therapeutic peptide candidate in Phase 3 development for the ...
Posted by Michael Wonder on 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to ...
Posted by Michael Wonder on 02 May 2024
US FDA approves high concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira
1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...