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Number of results: 2900
Date Compound Product name Company Disease Action mechanism Type of Information
2018-09-18 cabozantinib Cabometyx™ Exelixis (USA - CA) Ipsen (France)
  • advanced renal cell carcinoma
tyrosine kinase inhibitor.  Cabozantinib is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of… Granting of a Market Authorisation in Canada
2018-09-17 tildrakizumab Ilumetri®(EU)/Ilumya™ (USA - Australia) Merck&Co (USA - NJ) Sun Pharmaceutical Industries (India) Almirall (Spain)
  • moderate-to-severe plaque psoriasis
monoclonal antibody. Tildrakizumab is an anti-IL-23p19 monoclonal antibody. It selectively binds to the p19 subunit of IL-23 and inhibits its… Granting of a Market Authorisation in the EU
2018-09-15 fremanezumab Ajovy ® (fremanezumab -TEV-48125 -formerly LBR-101/ RN-307) Teva Pharmaceuticals (Israel) migraine monoclonal antibody. TEV -48125 (formerly LBR-101/ RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target… Granting of a Market Authorisation in the US
2018-09-14 ibalizumab Trogarzo™ TaiMed Biologics (Taiwan) Theratechnologies (Canada)
  • HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy
monoclonal antibody. Ibalizumab is a CD4-directed HIV entry-inhibitor and is the first humanized monoclonal antibody in clinical trials for the treatment of… Acceptation for review of a NDA
2018-09-13 moxetumomab pasudotox Lumoxiti® AstraZeneca (UK)
  • relapsed or refractory hairy cell leukemia (HCL)
antibody drug conjugate. Moxetumomab pasudotox is a CD22 immunotoxin composed of a binding portion of an anti-CD22 antibody fused to… Granting of a Market Authorisation in the US
2018-09-10 AT-GAA (ATB200/AT2221) Amicus Therapeutics (USA - NJ) Pompe disease enzyme replacement therapy. ATB200 is an engineered recombinant human acid alpha-glucosidase (rhGAA) enzyme with an optimized carbohydrate structure, administered in combination with a… Submission of a Market Application in the US
2018-09-10 orilanolimab SYNT001 - orilanolimab Syntimmune (USA - MA) pemphigus monoclonal antibody. SYNT001 is an investigational humanized IgG4 monoclonal antibody optimized to inhibit FcRn binding to IgG at both neutral… Granting of the orphan status in the US
2018-09-06 Virtrial (USA - AZ) Product launch
2018-09-05 tisagenlecleucel-T Kymriah® - CTL019 (tisagenlecleucel-T) Novartis (Switzerland)
  • patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse
cell therapy/gene therapy/CAR-T cell therapy. CTL019 is a personalized T cell therapy, which was pioneered by Carl June and his team… Granting of a Market Authorisation in the EU
2018-09-05 PF-06651600 Pfizer (USA - NY) alopecia areata janus kinase inhibitor/JAK3 inhibitor. PF-06651600, a newly discovered potent JAK3-selective inhibitor, is highly efficacious at inhibiting ?c cytokine signaling, which is… Granting of the Breakthrough Therapy status
2018-09-05 LOXO-292 LOXO-292 Loxo Oncology (USA - CT)
  • patients with metastatic RET-fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy
  • patients with RET-mutant medullary thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options
RET inhibitor/kinase inhibitor. LOXO-292 is an oral and selective investigational RET inhibitor. RET fusions have been identified in approximately 2% of… Granting of the Breakthrough Therapy status
2018-09-03 caplacizumab Cablivi® Ablynx (Belgium), now Sanofi (France) acquired thrombotic thrombocytopenic purpura (aTTP) nanobody. Caplacizumab is a bivalent anti-von Willebrand Factor (vWF) Nanobody. vWF is implicated in thrombotic thrombocytopenic purpura (TTP), a rare… Granting of a Market Authorisation in the EU
2018-08-31 neratinib Nerlynx® (PB272) Puma Biotechnology (USA - CA)
  • extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy
kinase inhibitor/tyrosine kinase inhibitor. PB272 (neratinib) is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor. It blocks mitogenic… Granting of a Market Authorisation in the EU
2018-08-31 daratumumab in combination with bortezomib, melphalan and prednisone Darzalex® in combination with bortezomib, melphalan and prednisone Janssen Biotech, a J&J company (USA - NJ)
  • adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma.… Granting of a Market Authorisation in the EU
2018-08-31 tislelizumab tislelizumab (BGB-A317) Beigene (China) relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL) monoclonal antibody/immune checkpoint inhibitor/immunomodulator. Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known… Acceptation for review of a NDA
2018-08-29 triheptanoin UX007 - triheptanoin Ultragenyx Pharmaceutical (USA - CA) long-chain 3-hydroxyacyl-coA dehydrogenase deficiency triglyceride. Triheptanoin is a purified, pharmaceutical-grade, specially designed synthetic triglyceride compound created via a multi-step chemical process. Triheptanoin is metabolized… Submission of an NDA
2018-08-27 volanesorsen - phosphorothioate oligonucleotide targeted to apolipoprotein C-III Waylivra™ Isis USA Ltd (UK) Isis Pharmaceuticals (USA - CA) Akcea Therapeutics (USA - MA) familial chylomicronaemia syndrome (FCS) antisense oligonucleotide. Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (ISIS-APOCIIIRxSIS-APOCIIIRx) is an antisense drug that targets apoC-III, a protein produced in… Refusal of a Market Autorisation in the US
2018-08-27 adenovirus associated viral vector serotype 8 containing the human Cyclic Nucleotide Gated Channel Alpha 3 subunit (CNGA3) gene AAV-CNGA3 - adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene MeiraGTx (USA - NY) achromatopsia caused by mutations in the CNGA3 gene gene therapy. ACHM is an inherited retinal disease that severely limits a person’s sight by preventing cone photoreceptors in the eye… Granting of the orphan status in the US
2018-08-27 vestronidase alfa-vjbk Mepsevii® Ultragenyx Pharmaceutical (USA - CA) mucopolysaccharidosis 7 (MPS 7, Sly syndrome) enzyme replacement therapy. Mucopolysaccharidosis 7 is caused by a deficiency of the lysosomal enzyme beta-glucuronidase, which is required for the breakdown… Granting of a Market Authorisation in the EU
2018-08-23 cytarabine and daunorubicin liposome injection Vyxeos™ Jazz Pharmaceuticals (Ireland) acute myeloid leukemia antimetabolite/antimitotic agent/cytotoxic agent. Vyxeos® is an advanced liposomal formulation that delivers a fixed-ratio (1:5) of daunorubicin and cytarabine. Daunorubicin has… Granting of a Market Authorisation in the EU