Opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in...
Synthetic peptide drugs less likely to be approved than recombinant peptide drugs
GlobalData’s Likelihood of Approval (LoA) tool in the Drugs database considers the case for pipeline recombinant peptide drugs.
Givlaari™ (givosiran) for the Treatment of Acute Hepatic Porphyria
Givlaari™ (givosiran) is the first aminolevulinic acid synthase 1 (ALAS1)-targeting RNAi drug indicated for the treatment of acute hepatic porphyria (AHP) in adults.
Abeona to initiate Phase III trial of EB-101 to treat RDEB
Abeona Therapeutics is ready to initiate its pivotal Phase III clinical trial, VIITAL, to evaluate EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
VUMERITY (diroximel fumarate) for the Treatment of Multiple Sclerosis
VUMERITY™ (diroximel fumarate), previously known as ALKS 8700, is a novel oral formulation indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Secuado (asenapine) for the Treatment of Schizophrenia
Secuado® (asenapine) is an atypical anti-psychotic drug approved for the treatment of schizophrenia in adult patients. It is the first drug approved as transdermal patch formulation for schizophrenia treatment in the US.
Vyvanse® (lisdexamfetamine) for the Treatment of Binge-Eating Disorder
Vyvanse® (lisdexamfetamine dimesylate) is a central nervous system (CNS) stimulant indicated for the treatment of moderate-to-severe binge-eating disorder and attention deficit hyperactivity disorder (ADHD).
FDA accepts Lilly’s protocol of pain trial for CID initiative
The US Food and Drug Administration (FDA) has accepted Eli Lilly’s pain clinical trial for the Complex Innovative Trial Designs (CID) Pilot Meeting Program.