Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
Aadi Bioscience announced that the company has initiated submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of advanced (metastatic or locally advanced) malignant PEComa (perivascular epithelioid-cell tumor) – a rare form of sarcoma driven by mTOR activation for which there is currently no approved therapy.
For the outstanding efficiency and scalability, high-performance liquid chromatography (HPLC) has been widely used for purification of high-quality APIs and intermediates in the pharmaceutical industry.
Leap Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for DKN-01 for the treatment of gastric and gastroesophageal junction cancer.
European biotech AlgoTherapeutix, an innovator in complex pain therapy, announces the U.S. Food and Drug Administration (FDA) has granted ATX01 (proprietary topical amitriptyline) Orphan Drug Designation for the treatment of erythromelalgia.
AVEO Oncology announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).
Bird Rock Bio has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.
GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has granted a priority review for the company’s application seeking approval of Nucala (mepolizumab) in the treatment of patients with Hypereosinophilic Syndrome (HES) in the US.
Novaremed is seeking the approval of the US Food and Drug Administration (FDA) to begin a phase 2 trial for evaluating its new drug candidate NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy (PDPN).
Tolero Pharmaceuticals, a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, TP-1454.
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