Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for filing and granted priority review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab, Bristol-Myers Squibb) for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC).
Acadia announced it has submitted to the Food and Drug Administration (FDA) a priority review of the New Drug Application (NDA) for Nuplazid (pimavanserin) for the treatment of Parkinson's disease psychosis (PDP).
Gilead announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infection met its primary objective.
Amgen and UCB announced top-line results from the STRUCTURE trial evaluating romosozumab in women with postmenopausal osteoporosis at high risk for fracture previously treated with bisphosphonate therapy.
Boehringer Ingelheim presented positive results of its Phase 3 RE-VERSE AD study for idarucizumab as a reversal agent for the anticoagulant effect of Pradaxa (dabigatran) in patients needing emergency surgery or for life-threatening or uncontrolled bleeding events.
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Empliciti (elotuzumab, Bristol-Myers Squibb/AbbVie) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.
The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.
Gilead Sciences announced positive results from the AMBITION study, a Phase 3/4 trial of first-line combination therapy with Letairis (ambrisentan) and tadalafil in patients with WHO/NYHA functional class II and III pulmonary arterial hypertension (PAH).
The Food and Drug Administration (FDA) has granted SYM-1219 (secnidazole, Symbiomix) Fast Track designation for the treatment of bacterial vaginosis (BV).
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for eteplirsen (Sarepta) for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
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