Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to 12 months sooner tha...
Otsuka ICU Medical recalls (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap label was incorrectly pr...
FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Ablation system to treat...
A new report from the Reagan-Udall Foundation calls for broad operational and policy reforms to improve the efficiency, representativeness, and succes...
FDA approves a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections.
Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.
FDA lifts a clinical hold against the Rein Therapeutics Phase 2 RENEW trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis.
FDA sends Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals Simponi (golimumab), due to deficiencies i...
