Over the past week, the FDA issued final guidances on enforcement for certain supplements for PMA or HDE submissions and clinical electronic thermometers enforcement policy. The agency is also proposing to…

In this edition of Quick Notes, we cover drug approvals for Roche’s Vabysmo for macular edema, Servier’s Tibsovo for treatment of IDH1, Coherus’ and Shanghai Junshi Biosciences’ Loqtorzi for nasopharyngeal cancer,…

After receiving an FDA notice of insanitary conditions at the Velocity Pharma supply plant, Cardinal Health and the Harvard Drug Group are voluntarily recalling all lots of their Velocity-produced ophthalmic…

In a guidance set to go into effect immediately, the FDA has made permanent the enforcement policy for use of clinical electronic thermometers it set during the COVID-19 public health…

A district court has ruled against an Alvogen subsidiary challenging the FDA’s rejection of its ANDA for a “skinny version” of Silax Pharmaceuticals’ blockbuster irritable bowel syndrome drug Xifaxan (rifaximin).…

Biotech products comprise nearly one-third of the $1.5 trillion global pharmaceutical market this year, according to a new Tufts Center for the Study of Drug Development (CSDD) study, with sales…

Vertex doesn’t need to do any more safety studies to identify potential off-target effects for exa-cel (exagamglogene autotemcel), its investigational gene-editing therapy designed to cure sickle cell disease, an FDA…

Despite missing its pivotal phase 3 primary efficacy endpoint, Sarepta is sailing confidently into a supplemental application to remove the age limitation on Elevidys (delandistrogene moxeparvovec-rokl), its gene therapy for…

CBER has launched an online crowdsourcing campaign that asks stakeholders what they see as the major advances in biological product development likely to emerge in the next three to ten…

Upcoming events in the coming weeks include three FDA advisory committee meetings as well as the 18th Annual Inspections vSummit from FDAnews, a WCG company, and webinars on how to…