Administration

Summary- The FDA has approved fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals) for the prevention of recurring Clostridioides difficile infection (CDI) among patients 18…

Summary : Pfizer and Ionis Pharmaceuticals announced that the former is abandoning its vupanorsen program for cardiovascular (CV) risk reduction and severe…

Summary – The Delhi High Court has published the final drafts of ‘High Court of Delhi Rules Governing Patent Suits, 2021’ and…

Synopsis: BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZOGO™ (Vosoritide) for Injection, indicated…

Abstract: The European Commission has approved Pfizer`s first-of-its-kind oral Janus kinase (JAK) inhibitor  XELJANZ® (Tofacitinib) 5 mg twice daily for the treatment…

SYNOPSIS US government contracts for approximately $1 billion (USD) are now in place to purchase Sotrovimab, further expanding access nationwide Sotrovimab, an…

SYNOPSIS: VUMERITY is a next-generation oral fumarate treatment for people with relapsing-remitting MS with established efficacy and well-characterized safety, building on Biogen’s…

SUMMARY: The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered to…

This information is provided to assist you if you are new to engaging with the TGA and Australia’s regulatory framework for medical…