After three decades of no new antibiotics for the treatment of gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection. The U.S. regulator has green lit Innoviva’s Nuzolvence a day after it granted an approval in the same indication to GSK’s Blujepa.

With an increase in the antimicrobial resistance to therapies for gonorrhea, doctors have been left with fewer options to treat the sexually transmitted infection. Thursday, the FDA addressed the shortfall with a label expansion for GSK’s Blujepa, which brings an oral option and a new class of antibiotic treatment for […]

As it shifts strategic direction to prioritize its recently acquired ENvue feeding tube placement system, NanoVibronix is changing its name to reflect the new focus.

On Thursday, the FDA green lit Uplizna to treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor and anti-muscle specific tyrosine kinase antibody positive. After two loading doses, Uplizna for gMG is administered just twice a year.

The long-planned legislation contains “encouraging steps” but is overall “not strong enough to move the needle” on European competitiveness, the European Federation of Pharmaceutical Industries and Associations said in a statement.

Abbott has put the ball back in Serena Williams’ court to serve up a high-profile endorsement of the Lingo over-the-counter glucose sensor.