Tags : US

Regulatory

Exelixis Reports the US FDA’s Acceptance of IND for XB002

Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. The P-I trial is expected to initiate in Q2’21 The preclinical data demonstrated that XB002 binds to tissue factors without affecting the coagulation cascade, in contrast with prior therapies in […]Read More

Regulatory

Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy

Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The findings will be presented at AACR 2021 The preliminary clinical evidence showed improvement on at least one clinical EPs over available therapy Futibatinib (TAS-120, PO) is a covalently-binding FGFR inhibitor […]Read More

Regulatory

Althera’s Roszet (rosuvastatin and ezetimibe) Receives the US FDA’s Approval

Shots: The US FDA has approved Roszet for the treatment of elevated LDL-C in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia The result showed a reduction of LDL cholesterol by 72% with 40mg/10mg dose and 64% with 10 mg/10mg dose. The level of LDL-reduction indicates from both the statin component i.e rosuvastatin […]Read More