Epizyme, a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Cosentyx (secukinumab) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).
Jazz Pharmaceuticals and PharmaMar have secured accelerated approval from the US Food and Drug Administration (FDA) for Zepzelca (lurbinectedin) for the treatment of metastatic small cell lung cancer (SCLC).
NeoImmuneTech, a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NeoImmuneTech’s NT-I7 (efineptakin alfa), the only clinical-stage long-acting human IL-7, for the treatment of Progressive Multifocal Leukoencephalopathy (PML).
ViiV Healthcare has been granted approval by the US Food and Drug Administration (FDA) for Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension for the treatment of human immunodeficiency virus type 1 (HIV-1) in infants and children.
Vertex Pharmaceuticals has secured approval from the European Commission (EC) for its Kalydeco (ivacaftor) to treat children and adolescents with cystic fibrosis (CF).
Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin, and relebactam) to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Pierre Fabre has secured approval from the European Commission (EC) for Braftovi (encorafenib) plus cetuximab (Erbitux) to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.
AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Brilinta (ticagrelor) to minimise the risk of a first heart attack or stroke in high-risk patients with a heart disease known as coronary artery disease (CAD).
Genentech has secured approval from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
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