Even as antimicrobial resistance is expected to continue to grow, the development of much-needed novel antibiotics and antifungals remains trapped in a catch-22 in which funding is available for early stage research but not necessarily for the translational work necessary to bring the drugs to market.

The FDA has removed an obstacle to Provention Bio Inc.’s development of teplizumab in treating type 1 diabetes.

The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot. 

Biomarin Pharmaceutical Inc.’s data supporting the use of Voxzogo (vosoritide) in children with the most common form of dwarfism proved compelling for the FDA, which cleared the modified C-type natriuretic peptide as the first treatment for the rare genetic disease affecting bone growth.

Dublin-based Medtronic plc’s Micra pacemaker was a groundbreaking device when the FDA approved the leadless pacemaker in 2016, thanks to the elimination of the hazards associated with pacemaker leads. However, the FDA said recently that the risks associated with cardiac perforation with leadless pacemakers, such as tamponade or death, might be higher with the Micra than with pacemakers with leads.

LONDON – The first commercial implantations of Istar Medical SA’s minimally invasive Miniject supraciliary glaucoma drainage device have taken place in Germany, following European CE approval for the product.