New Drug Application
- Business Wire
Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan
NDA filed in Japan ahead of anywhere else in the world New anti-cancer drug with a novel mechanism of action…
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Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer
− Prescription Drug User Fee Act (PDUFA) Target Action Date Set for October 26, 2021 CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS…
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Takeda Submits New Drug Application in Japan for Lanadelumab as a Preventive Treatment for Hereditary Angioedema Attacks
Osaka, Japan: — Lanadelumab is an investigational monoclonal antibody for the preventive treatment of hereditary angioedema (HAE) in patients 12…
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GNT Pharma’s GedaCure® Approved for the Treatment of Dogs With Cognitive Dysfunction Syndrome
Yongin, South Korea: GNT Pharma today announced the Korea Animal and Plant Quarantine Agency (APQA) has approved the New Drug…
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U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
Osaka, Japan & Cambridge, Mass., United States: – Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to CP-CML Patients with Resistance…
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