KalVista initiates KONFIDENT-KID trial for on-demand treatment of hereditary angioedema attacks with sebetralstat in children aged 2 to 11 KalVista...
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KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for Hereditary Angioedema KalVista Pharmaceuticals, Inc, today announced the submission of a New Drug Application (NDA) for US Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema [...]
KalVista initiates KONFIDENT-KID trial for on-demand treatment of hereditary angioedema attacks with sebetralstat in children aged 2 to 11 KalVista...
SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with...
SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with...
STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused...
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The FDA accepts Vertex's (VRTX) new drug application for vanza triple therapy for people living with cystic fibrosis aged six years and above. A...
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NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...
BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...