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RSS FeedPosted by Michael Wonder on 27 Jan 2023
Valeo Pharma announces filing of a new drug submission with Health Canada for sabizabulin for the treatment of hospitalised COVID-19 patients
26 January 2023 - In the final analysis of the Phase 3 clinical study conducted by Veru, sabizabulin showed a 51.6% ...
Posted by Michael Wonder on 27 Jan 2023
Marketing authorisation application for lecanemab as treatment for early Alzheimer's disease accepted by EMA
27 January 2023 - Eisai and Biogen announced today that the EMA has accepted a marketing authorisation application for lecanemab, an ...
Posted by Michael Wonder on 24 Jan 2023
Fabre-Kramer Pharmaceuticals announces FDA acceptance of NDA resubmission as complete response and assignment of PDUFA regulatory action date
24 January 2023 - Submission of Exxua (gepirone hydrochloride), a novel targeted single serotonin receptor agonist for treatment of major ...
Posted by Michael Wonder on 24 Jan 2023
Verrica Pharmaceuticals announces resubmission of new drug application for VP-102 for the treatment of molluscum contagiosum
24 January 2023 - Potential first FDA approved therapy for treatment of molluscum contagiosum. ...
Posted by Michael Wonder on 23 Jan 2023
Blueprint Medicines announces FDA acceptance of supplemental new drug application for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis
23 January 2023 - FDA grants priority review and sets PDUFA action date of 22 May 2023. ...
Posted by Michael Wonder on 23 Jan 2023
The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children
23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...
Posted by Michael Wonder on 23 Jan 2023
TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for potential transition to full registration
20 January 2023 - The TGA has commenced evaluation of an application from Moderna to transition its COVID-19 vaccine, Spikevax, ...
Posted by Michael Wonder on 20 Jan 2023
US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
20 January 2023 - The supplemental new drug application is based on results from the landmark EMPA-KIDNEY Phase 3 trial, which ...
Posted by Michael Wonder on 20 Jan 2023
Opiant Pharmaceuticals announces FDA acceptance and priority review of NDA for OPNT003, nasal nalmefene, for opioid overdose
19 January 2023 - FDA sets PDUFA date of 22 May 2023. ...
Posted by Michael Wonder on 20 Jan 2023
US FDA issues complete response letter for accelerated approval of donanemab
19 January 2023 - Complete response letter based on limited number of patients with 12 month drug exposure data in the ...
Posted by Michael Wonder on 19 Jan 2023
FDA accepts Intercept’s new drug application for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH
19 January 2023 - PDUFA target action date set for 22 June 2023. ...
Posted by Michael Wonder on 19 Jan 2023
Health Canada accepts nirsevimab regulatory submission for infant RSV
18 January 2023 - Nirsevimab is the first investigational long-acting antibody designed for all infants to help protect against respiratory syncytial ...
Posted by Michael Wonder on 13 Jan 2023
Daiichi Sankyo submits application for marketing approval of mRNA COVID-19 vaccine (DS-5670) in Japan
13 January 2023 - Daiichi Sankyo today announced the submission of an application for marketing approval of DS-5670 to the ...
Posted by Michael Wonder on 12 Jan 2023
Eton Pharmaceuticals announces FDA acceptance of NDA response for dehydrated alcohol injection
11 January 2023 - Application assigned a PDUFA date of 27 June 2023. ...
Posted by Michael Wonder on 12 Jan 2023
Eisai submits marketing authorisation application for lecanemab as treatment for early Alzheimer's disease in Europe
11 January 2023 - Eisai and Biogen announced today that Eisai has submitted a marketing authorisation application for lecanemab, an investigational ...