GlaxoSmithKline has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] for the development of the vaccine in the prevention of Invasive Meningococcal Disease (IMD) caused by serogroup B in children 2-10 years of age.
The US Food and Drug Administration (FDA) has granted the regenerative medicine advanced therapy (RMAT) designation for Capricor Therapeutics’ investigational cell therapy for the treatment, CAP-1002, to treat Duchenne muscular dystrophy.
The US Food and Drug Administration (FDA) has approved Allergan's supplemental new drug application (sNDA) to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Amgen has received a positive opinion from the Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to add updated overall survival data to Kyprolis label.
Advanced Accelerator Applications’ radioactive drug Lutathera (lutetium Lu 177 dotatate) has been approved by the US Food and Drug Administration (FDA) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Genmab announced that the US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
AstraZeneca has secured approvals for its cancer drug Lynparza (olaparib) and asthma drug Fasenra (benralizumab) from the Japanese Ministry of Health, Labour and Welfare for the treatments of ovarian cancer and bronchial asthma, respectively.
Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) has been granted fast-tracked reviews in the US and Europe for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been earlier treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
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