More than two years after receiving an FDA rejection, Mesoblast has resubmitted its biologics license application (BLA) for remestemcel-L, a treatment for children afflicted with steroid-refractory acute graft vs. host…

In this special report, Drug Industry Daily examines how the drug supply chain has evolved during the pandemic. Part 2 focuses on efforts to shore up the supply chain, including…

In two newly issued annual reports, the FDA’s Center for Drug Evaluation and Research (CDER) showcases its achievements in 2022. Source: Drug Industry Daily

Bayer and EMD Serono have joined the list of drugmakers limiting the discounts they provide to participating 340B hospitals. Source: Drug Industry Daily

In this special report, Drug Industry Daily examines how the drug supply chain has evolved during the pandemic. Part 1 focuses on the special challenges to manufacturers of generics. Source:…

Lyne Laboratories’ Brockton, Mass., drug manufacturing facility was handed a seven-observation Form 483 for inadequate investigations of complaints, lax batch records and other deficiencies. Source: Drug Industry Daily

Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture but measuring the maturity of that culture takes more…

Fezolinetant, Astellas Pharma’s potential first-in-class treatment for menopausal hot flashes, shouldn’t cost more than $2,600 per year if approved, according to a cost-benefit analysis by the Institute for Clinical and…

The FDA has asked for feedback on an International Council for Harmonization (ICH) draft guideline on bioequivalence (BE) studies for immediate-release solid oral drugs. Source: Drug Industry Daily

In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that…