The FDA issued a Complete Response Letter rejecting the New Drug Application (NDA) for Zynquista (sotagliflozin; Sanofi and Lexicon) for the treatment of adults with type 1 diabetes, in combination with insulin.
Enzyvant announced that the Food and Drug Administration (FDA) has granted RVT-801 both Rare Pediatric Disease and Fast Track designations for Farber disease.
Jazz Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…
Merck and Pfizer announced the discontinuation of the phase 3 JAVELIN Ovarian PARP 100 study that was comparing the safety and efficacy of avelumab plus chemotherapy followed by avelumab plus talazoparib (Talzenna) vs an active comparator in treatment-naive patients with locally advanced or metastatic ovarian cancer (stage III or IV).
The Food and Drug Administration (FDA) has placed a partial hold on all clinical trials evaluating venetoclax (Venclexta; AbbVie and Genentech) for the treatment of multiple myeloma. This was prompted after a review of data from the phase 3 BELLINI trial (M14-031) showed a higher proportion of deaths in the venetoclax treatment arm compared with…
Urovant Sciences announced topline data from the phase 3 EMPOWUR trial which evaluated vibegron in adult patients with symptoms of overactive bladder.
Results from a real-world study evaluating rivaroxaban (Xarelto; Janssen) in newly diagnosed patients with nonvalvular atrial fibrillation (NVAF) were presented at the American College of Cardiology’s (ACC) 68th Annual Scientific Session.
A new granule formulation of Prograf (tacrolimus; Astellas) has been made available for the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, in combination with other immunosuppressants.
Drug overdoses resulted in approximately 72,000 deaths in the US, according to the CDC.
