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Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile neutropenia after chemotherapy. Read More
The FDA delivered a couple of unwelcome holiday gifts to two hopeful sponsors in the form of Complete Response Letters (CRL) — one for Merck’s chronic cough drug gefapixant and the second for Zealand Pharma’s dasiglucagon, an investigational agent intended to treat congenital hyperinsulinism. Read More
A recent study raises questions about the safety of Sage Therapeutics’ Zurzuvae (zuranolone) for postpartum depression, charging that the drug exerts risks similar to those seen with benzodiazepines and that the clinical trials supporting its approval were inappropriately conducted. Read More
In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who require systemic treatment, Fabhalta an oral monotherapy for the treatment of PNH and a priority review voucher award for Genzyme. Read More
Two cell-based gene therapies to treat sickle cell disease — Casgevy (exagamglogene autotemcel or exa-cel) and Lyfgenia (lovotibeglogene autotemcel or lovo-cel) — received FDA approval Friday, marking the first treatments to provide potential life-long elimination of severe disease symptoms. Read More
As action dates for two groundbreaking sickle cell gene therapies loom, U.S. Senator Bill Cassidy, MD (R-LA), is raising questions about the cost, and how these extremely expensive, but life-changing, treatments will be paid for and allocated. Read More
Drug containers contaminated with wood, cellulose, brass and steel as well as multiple corrective and preventive actions (CAPA) to address mold are among the reasons the FDA listed in its untitled letter to Novartis Pharmaceuticals over its biological product Kymriah (tisagenlecleucel). Read More
In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the popularity of these drugs also continues to expand. Read More
Aldeyra Therapeutics on Monday announced receipt of an FDA complete response letter (CRL) for the NDA of reproxalap, for the treatment of dry eye disease, asking the company to conduct an additional trial to show the efficacy of the drug. Read More