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News about "New Drug Application "
PTC Therapeutics Submits NDA for Vatiquinone to FDA
The vatiquinone NDA is based on data from the placebo-controlled MOVE-FA study as well as results from two long-term studies including pediatric and adult FA patients.
New Drug Application | 24/12/2024 | By Aishwarya
Ionis Receives FDA Approval of New Drug Application for Donidalorsen
Donidalorsen is designed to reduce the production of prekallikrein (PKK), interrupting the pathway that leads to HAE attacks.
New Drug Application | 06/11/2024 | By Aishwarya
Antengene Receives Approval for XPOVIO for Commercialisation in Thailand
This successful approval for XPOVIO in Thailand will introduce novel therapies to the clinical management of patients with MM in Thailand, benefiting many patients and their families in the country.
New Drug Application | 24/09/2024 | By Aishwarya | 101
Antengene Gets Malaysian Regulatory Agency Approval for XPOVIO Commercialization
Antengene has announced that Malaysian National Pharmaceutical Regulatory Agency has approved a New Drug Application (NDA) for XPOVIO (selinexor).
New Drug Application | 06/08/2024 | By Aishwarya | 129
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