AstraZeneca’s MEDI8897 has secured breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV).
Roche has submitted a supplemental biologics license application (sBLA) in the US seeking approval for Kadcyla (trastuzumab emtansine) for the adjuvant treatment of a type of early breast cancer.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Merck’s Keytruda plus chemotherapy to treat metastatic squamous non-small cell lung cancer (NSCLC).
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s Forxiga (dapagliflozin) to treat adults with type-1 diabetes (T1D).
Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its V114 investigational 15-valent pneumococcal conjugate vaccine.
Vertex Pharmaceuticals announced that Health Canada has granted Market Authorization for KALYDECO (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Johnson & Johnson (J&J) and AbbVie have secured approval from the US Food and Drug Administration (FDA) for Imbruvica plus obinutuzumab as non-chemotherapy combination regimen for treatment- naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
The US Food and Drug Administration (FDA) has accepted X-Rx's investigational new drug application (IND) for X-165 being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Clovis Oncology has secured approval from the European Commission (EC) for its Rubraca (rucaparib) as maintenance treatment for women with relapsed ovarian cancer.
Amgen announced that the European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.
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