The kappa opioid receptor agonist is not listed as a scheduled substance and labeling meets expectations. Cara and partner Vifor plan to launch the product in early 2022.

The effect of low-dose psilocybin, a compound found in mushrooms, on a rare debilitating condition, short-lasting unilateral neuralgiform headaches attacks, is to be evaluated by the 2019-founded UK biotech, Beckley Psytech.

Rockwell Medical has filed an NDA for the iron replacement therapy, which will be positioned as an alternative to I.V. iron during dialysis and could limit the need for erythropoietin-stimulating agents.

The company is shipping Neutrolin, a device containing an antimicrobial/antifungal agent and two anti-clotting agents, in Germany to “lock” catheters between dialysis sessions and prevent blood stream infections and clots. The New Jersey firm also is working with FDA to get the product approved in the U.S. as a specialty pharmaceutical.