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RSS FeedPosted by Michael Wonder on 29 Nov 2023
Karuna Therapeutics announces US FDA accepts new drug application for KarXT for the treatment of schizophrenia
29 November 2023 - PDUFA action date is 26 September 2024. ...
Posted by Michael Wonder on 29 Nov 2023
Foslevodopa with foscarbidopa for the treatment of patients with advanced Parkinson’s with motor symptoms
29 November 2023 - NICE has published final evidence-based recommendations on the use of foslevodopa with foscarbidopa (Produodopa) for the ...
Posted by Michael Wonder on 29 Nov 2023
eFFECTOR receives US FDA fast track designation for zotatifin in combination with fulvestrant and abemaciclib for treatment of ER positive/HER2 negative advanced metastatic breast cancer
28 November 2023 - Designation is for second or third-line treatment of patients with disease progression following treatment with endocrine therapy ...
Posted by Michael Wonder on 28 Nov 2023
ICER releases draft evidence report on treatment for schizophrenia
28 November 2023 - Public comment period now open until 22 December 2023; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 28 Nov 2023
Orexo announces FDA acceptance of new drug application filing for OX124, a high-dose rescue medication for opioid overdose
28 November 2023 - PDUFA set to 15 July 2024. If approved, US launch is expected to be initiated late ...
Posted by Michael Wonder on 28 Nov 2023
Aldeyra Therapeutics receives complete response letter from the US FDA for the reproxalap new drug application for the treatment of dry eye disease
27 November 2023 - Additional trial required to demonstrate positive effect on the treatment of ocular symptoms in dry eye disease. ...
Posted by Michael Wonder on 27 Nov 2023
FDA approves nirogacestat for desmoid tumours
27 November 2023 - Today, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics) for adult patients with progressing desmoid tumours who ...
Posted by Michael Wonder on 27 Nov 2023
Lifeline for Wolman disease kids as NICE backs Alexion drug
27 November 2023 - Infants with a rare and fatal congenital disorder called Wolman disease in England and Wales will ...
Posted by Michael Wonder on 27 Nov 2023
Novartis urges Court to hand it quick win in drug price battle
25 November 2023 - Medicare’s drug price negotiation program violates the Constitution and must be struck down, Novartis Pharmaceuticals said ...
Posted by Michael Wonder on 27 Nov 2023
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
Posted by Michael Wonder on 27 Nov 2023
Krystal Biotech announces EMA validation of marketing authorisation application for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
27 November 2023 - Vyjuvek received orphan drug designation and PRIME designation from the EMA. ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 27 Nov 2023
ONO receives supplemental approval of Opdivo in Japan for expanded use for treatment of malignant mesothelioma (excluding malignant pleural mesothelioma)
24 November 2023 - Ono Pharmaceutical today announced that ONO has received supplemental approval of Opdivo (nivolumab) intravenous infusion, a ...
Posted by Michael Wonder on 27 Nov 2023
Cheaper medicines and more bulk billing
27 November 2023 - Australians are on track to save a quarter of a billion dollars on their medicines in 2023, ...
Posted by Michael Wonder on 26 Nov 2023
Xtandi to get expanded coverage for metastatic hormone sensitive prostate cancer next month
31 October 2023 - Prostate cancer drug Xtandi (enzalutamide), in combination with androgen deprivation therapy to treat patients with metastatic ...