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.
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.
The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).
Sanofi Pasteur has secured approval from the US Food and Drug Administration (FDA) for its Dengvaxia vaccine for the prevention of dengue disease in endemic regions.
Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO (ivacaftor) for use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.
Finch Therapeutics Group announced that the US Food and Drug Administration (FDA) has granted fast track designation to its Full-Spectrum Microbiota (FSM) therapy for the treatment of children with Autism Spectrum Disorder (ASD).
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE).
Knopp Biosciences announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES).
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