Takeda Pharmaceuticals, announced today that the US Food and Drug Administration (FDA) approved extending the indication of GATTEX (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding.
Pfizer has secured approval from the US Food and Drug Administration (FDA) for the subcutaneous use of Fragmin (dalteparin sodium) injection for the treatment of potentially life-threatening blood clots in pediatric patients.
Roche has secured approval from the US Food and Drug Administration (FDA) for its Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) to treat people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Pfizer and Merck have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) in combination with Inlyta (axitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC).
Eli Lilly announced that the US Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
Celgene has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Pomalyst (pomalidomide) to treat patients with human immunodeficiency virus (HIV)-positive and negative Kaposi sarcoma.
Sunovion Pharmaceuticals and PsychoGenics have secured the breakthrough therapy designation from the US Food and Drug Administration (FDA) for their jointly owned psychotropic agent SEP-363856 for the treatment of schizophrenia.
Pfizer announced that the European Commission (EC) granted conditional marketing authorization for LORVIQUA (lorlatinib, available in the US, Canada and Japan under the brand name LORBRENA), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI. LORVIQUA is a third-generation ALK TKI that was specifically developed to penetrate the blood brain barrier, in the presence or absence of resistance mutations.
Roche has secured approval from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) Kadcyla (trastuzumab emtansine) for the adjuvant treatment of HER2-positive early breast cancer in certain patient population.
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) to treat patients with transthyretin amyloid cardiomyopathy.
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