BioSpace News Archive

CN Bio, a leading Organ-on-a-chip Company (OOC) that designs and manufactures single- and multi-organ microphysiological systems (MPS), today announced the appointment of Dr Paul Brooks as Chief Business Officer.

Neuronascent Inc. announced that the US Food and Drug Administration granted rare pediatric designation for NNI-351 for Fragile X syndrome.

MannKind Corporation celebrated that the U.S. Food and Drug Administration has approved United Therapeutics’ Tyvaso DPI™ inhalation powder for the treatment of patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Dermavant Sciences announced that the U.S. Food and Drug Administration has approved VTAMA® cream, 1%, an aryl hydrocarbon receptor agonist, indicated for the topical treatment of plaque psoriasis in adults.

CareDx, Inc. announced that it has received CE marking for its AlloSeq HCT chimerism testing kit and AlloSeq HCT interpretation software for use in patients who have received hematopoietic cell transplantation.

Blue Lake Biotechnology, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus associated disease in adults over 60 and children under 2 years of age.

Electromedical Technologies, Inc. is pleased to provide its Financial and Operational Highlights for the three months ended March 31, 2022.

United Therapeutics Corporation, a public benefit corporation, announced that the U.S. Food and Drug Administration has approved Tyvaso DPI™ inhalation powder for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability.

Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved the Company’s Abbreviated New Drug Application for Regadenoson injection, 0.08 mg/mL, 5mL Single Dose Pre-Filled Syringe.

CB Scientific. Inc., a designer, manufacturer, and distributor of non-invasive ambulatory cardiac monitoring products and services, announced that it has entered the regulatory testing phase for its updated myCam cardiac event monitoring device.