Approvals

FDA grants breakthrough therapy designation for GSK’s meningitis B vaccine Bexsero

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.

Capricor gets FDA RMAT designation for CAP-1002 to treat Duchenne muscular dystrophy therapy

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.

FDA approves Avycaz to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

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 receives CHMP positive opinion to add updated overall survival data to Kyprolis label

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.

FDA approves Advanced Accelerator’s Lutathera for certain digestive tract cancers

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).

FDA grants priority review for daratumumab in front line multiple myeloma

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 secures approvals for cancer and asthma drugs in Japan

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’ Kymriah nabs speedy reviews in US, Europe for lymphoma treatment

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).

Shire’s haemophilia A drug Adynovi secures approval in Europe

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.