Quality Systems

FDA Approves UCB Generalized Myasthenia Gravis Treatment

June 30, 2023

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

FDA Approves Pfizer Human Growth Hormone Analog

June 29, 2023

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

NCI Launches Persistent Poverty Initiative

June 29, 2023

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA

June 27, 2023

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

FDA Releases Psychedelic Drugs Draft Guidance

June 26, 2023

FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.

FDA Releases Updated COVID-19 Vaccine Guidelines

June 21, 2023

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk

June 21, 2023

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

Long-Admired PEPFAR Program Caught in Abortion Debate

June 16, 2023

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

Merck Files Lawsuit Against US Government

June 08, 2023

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

MilliporeSigma Invests €35 Million to Strengthen Biosafety Testing in Scotland

June 07, 2023

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.