Blog
RSS FeedPosted by Michael Wonder on 11 Aug 2023
US FDA designates PYC's lead as a fast track development program
11 August 2023 - The Company is currently evaluating the safety/tolerability and efficacy of an investigational drug candidate with disease-modifying potential ...
Posted by Michael Wonder on 10 Aug 2023
US FDA accepts Astellas' sNDA for Cresemba (isavuconazonium sulphate) in children
10 August 2023 - Astellas announced that the US FDA has accepted the company's supplemental new drug application for Cresemba (isavuconazonium ...
Posted by Michael Wonder on 10 Aug 2023
FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma
10 August 2023 - On 9 August 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech) for adults with ...
Posted by Michael Wonder on 10 Aug 2023
How a controversial US drug policy could be harming cancer patients worldwide
9 August 2023 - The FDA’s accelerated approval process was designed to help people access life saving drugs. ...
Posted by Michael Wonder on 09 Aug 2023
Galera receives complete response letter from US FDA for avasopasem manganese
9 August 2023 - The Company remains committed to its goal of bringing avasopasem manganese to patients and intends to meet ...
Posted by Michael Wonder on 09 Aug 2023
FDA approves pralsetinib for non-small-cell lung cancer with RET gene fusions
9 August 2023 - Today, the FDA granted regular approval to pralsetinib (Gavreto, Genentech) for adult patients with metastatic rearranged ...
Posted by Michael Wonder on 09 Aug 2023
Public pharma is the best solution to the on-going problem of drug shortages
9 August 2023 - Drug shortages in the United States are at a record high. At least 14 essential generic ...
Posted by Michael Wonder on 07 Aug 2023
Viatris and Mapi Pharma announce FDA acceptance of new drug application filing for glatiramer acetate depot for the treatment of relapsing forms of multiple sclerosis
7 August 2023 - FDA assigns PDUFA target action date of 8 March 2024. ...
Posted by Michael Wonder on 07 Aug 2023
FDA approves Zurzuvae (zuranolone), the first and only oral treatment approved for women with postpartum depression, and issues a complete response letter for major depressive disorder
4 August 2023 - Post partum depression approval based on results from two Phase 3 clinical trials; in the SKYLARK study ...
Posted by Michael Wonder on 06 Aug 2023
Free the PrEP - over the counter access to HIV pre-exposure prophylaxis
5 August 2023 - Several barriers to access to preexposure prophylaxis for HIV could be alleviated by making it available over ...
Posted by Michael Wonder on 05 Aug 2023
Basilea announces submission of a new drug application to the US FDA for its antibiotic ceftobiprole
4 August 2023 - Seeking approval for Staphylococcus aureus bacteraemia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. ...
Posted by Michael Wonder on 05 Aug 2023
Iveric Bio receives US FDA approval for Izervay (avacincaptad pegol intravitreal solution), a new treatment for geographic atrophy
5 August 2023 - Izervay is the only approved GA treatment with a statistically significant reduction in the rate of geographic ...
Posted by Michael Wonder on 05 Aug 2023
FDA approves first oral treatment for post-partum depression
4 August 2023 - Today, the US FDA approved Zurzuvae (zuranolone), the first oral medication indicated to treat post-partum depression in ...
Posted by Michael Wonder on 04 Aug 2023
Mesoblast receives complete response from US FDA for biologics license application for steroid-refractory acute graft versus host disease in children
4 August 2023 - Mesoblast Limited today announced that the US FDA has provided a complete response to its biologics license ...
Posted by Michael Wonder on 03 Aug 2023
Aardvark Therapeutics announces receipt of FDA rare paediatric disease designation for Prader-Willi syndrome
3 August 2023 - Aardvark's Phase 2 trial of oral ARD-101 in young adults with Prader-Willi syndrome is now open ...