Pharma News

The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.

The US Food and Drug Administration (FDA) has issued final guidance in the form of a question-and-answer guide to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the...

The latest on potential COVID-19 treatments, vaccines, and diagnostics with news from GSK, Apple, Google, Fujifilm, Inovio, and CanSino Biologics, and Covis Pharma. News from GSK, Apple, Google and Fujifilm GSK, Mammoth Biosciences To Develop...

The European Medicines Agency (EMA) is waiving fees for on-site GMP inspections of drug makers and blood establishments that have undergone remote inspections during COVID-19. Plasma Master Files inspections are also in the scope of this...

The US Food and Drug Administration has issued guidance documents to help accelerate the development of prevention and treatment options for COVID-19. The FDA says the guidances make the process for submitting applications to initiate studies for...

Bristol Myers Squibb (BMS) and bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, have received a Refusal to File Letter from the US Food and Drug Administration (FDA) regarding the biologics license...