Novartis plans to file for new Lucentis indication in ROP
Novartis has unveiled plans to file ex-US for a new indication for Lucentis (ranibizumab) in retinopathy of prematurity (ROP), a rare disease in premature infants.
Novartis has unveiled plans to file ex-US for a new indication for Lucentis (ranibizumab) in retinopathy of prematurity (ROP), a rare disease in premature infants.
OBI Pharma’s small-molecule prodrug OBI-3424 has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute lymphoblastic leukemia (ALL).
Ironwood Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.
Alexion Pharmaceuticals said that it has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA), seeking approval for its C5 complement inhibitor ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration seeking approval of risankizumab for the treatment of moderate to severe plaque psoriasis.
Sarepta Therapeutics has is planning to submit a new drug application (NDA) for accelerated approval of its duchenne muscular dystrophy (DMD) drug Golodirsen (SRP-4053).
Alnylam Pharmaceuticals and Sanofi Genzyme have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Pharming Group has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).
Janssen Biotech has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC).