Blog
RSS FeedPosted 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
US FDA approves Merck’s Ervebo (Ebola Zaire vaccine, live) for use in children 12 months of age and older
3 August 2023 - Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease. ...
Posted by Michael Wonder on 02 Aug 2023
FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer
2 August 2023 - Today, the FDA approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) with bevacizumab, for metastatic colorectal cancer ...
Posted by Michael Wonder on 31 Jul 2023
FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer
31 July 2023 - Today, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for ...
Posted by Michael Wonder on 30 Jul 2023
Citius Pharmaceuticals receives a complete response letter from the US FDA for Lymphir (denileukin diftitox) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma
29 July 2023 - No clinical efficacy or safety issues raised. ...
Posted by Michael Wonder on 28 Jul 2023
FDA approves second over the counter naloxone nasal spray product
28 July 2023 - Today, the US FDA approved RiVive, 3 mg naloxone hydrochloride nasal spray for over the counter, non-prescription ...
Posted by Michael Wonder on 26 Jul 2023
Octapharma's prothrombin complex concentrate, Balfaxar, receives FDA approval for warfarin reversal in urgent surgery & invasive procedures
26 July 2023 - Octapharma USA today announced that Balfaxar (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as ...
Posted by Michael Wonder on 25 Jul 2023
FDA approves Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis
25 July 2023 - Xdemvy expected to be available by prescription by the end of August 2023. ...
Posted by Michael Wonder on 22 Jul 2023
Verrica Pharmaceuticals announces FDA approval of Ycanth (cantharidin) topical solution as the first FDA approved treatment of paediatric and adult patients with molluscum contagiosum
21 July 2023 - Ycanth is a drug-device combination product administered by a health care professional; Verrica plans to make Ycanth ...
Posted by Michael Wonder on 22 Jul 2023
Invivoscribe announces FDA approval of the LeukoStrat CDx FLT3 mutation assay to select patients with FLT3 ITD positive AML for treatment with Vanflyta
21 July 2023 - Invivoscribe is excited to announce that the LeukoStrat CDx FLT3 mutation assay has been approved by ...
Posted by Michael Wonder on 21 Jul 2023
Emergent BioSolutions receives US FDA approval of Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, a two dose anthrax vaccine for post-exposure prophylaxis use
20 July 2023 - Emergent has been delivering Cyfendus vaccine to the US Department of Health and Human Services since ...
Posted by Michael Wonder on 20 Jul 2023
FDA approves quizartinib for newly diagnosed acute myeloid leukaemia
20 July 2023 - Today, the FDA approved quizartinib (Vanflyta, Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine ...
Posted by Michael Wonder on 17 Jul 2023
FDA approves new drug to prevent RSV in babies and toddlers
17 July 2023 - Today, the US FDA approved Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus lower respiratory tract ...