FDA has cleared the first seven tesla (7T) magnetic resonance imaging device, more than doubling the static magnetic field strength available for use in the U.S.
Takeda Pharmaceutical Co. Ltd. said FDA has approved the supplemental new drug application for Alunbrig (brigatinib) 180 mg tablets.
Genentech, a member of the Roche Group, said FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer.
Mylan N.V. announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's Gleevec Tablets.
Amgen and CytomX Therapeutics Inc. have entered into a collaboration in immuno-oncology that will allow the companies to co-develop a CytomX Probody T-cell engaging bispecific against the epidermal growth factor receptor. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX’s Probody versions of EGFRxCD3 bispecific […]
Kymriah (tisagenlecleucel) became the first gene therapy available in the United States.
FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones. Verzenio, sponsored by Eli Lilly, is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread.
FDA has approved Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Amgen has reached a global settlement with AbbVie to resolve all pending litigation regarding Amgevita/Amjevita, a biosimilar to AbbVie's Humira (adalimumab).
FDA approved a new label for Odomzo (sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
